Quality

Amgen

Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence**

**What you will do**

Lets do this. Lets change the world. The Senior Director is the single accountable leader for Amgens global GMP/GDP audit organization and predictive compliance intelligence capability.

The role leads an integrated enterprise function combining independent audit assurance, deep Operations compliance expertise, advanced analytics, AI-enabled tools, regulatory intelligence, inspection outcomes, supplier performance, and internal quality signals.

The Senior Director is accountable for the technical depth, strategic direction, execution, and effectiveness of the global audit program while building a forward-looking capability that identifies emerging compliance risks and enables earlier enterprise intervention.

The role leads two fully integrated capabilities:

- Global GMP/GDP Audit, including internal audits of manufacturing sites, programs, and quality systems, and audits of suppliers, contract manufacturers, laboratories, distributors, and other regulated service providers.
- Predictive Compliance Intelligence, focused on identifying weak signals, forecasting compliance vulnerabilities, detecting systemic trends, and translating intelligence into audit priorities and broader risk-mitigation actions.

The function is intended to move the organization beyond retrospective identification of deficiencies toward earlier detection, prioritization, and prevention of significant regulatory and quality risks.

**Key Responsibilities**

- Serve as the single accountable leader for the global GMP/GDP audit organization and predictive compliance intelligence capability.
- Establish the strategic direction, operating model, technical standards, and multiyear roadmap for both capabilities.
- Lead the global risk-based GMP/GDP audit strategy and master audit schedule.
- Ensure the audit program maintains sufficient technical depth to evaluate manufacturing operations, laboratories, quality systems, suppliers, contract manufacturers, and distribution activities.
- Oversee audit planning, scope, execution, finding classification, reporting, CAPA assessment, effectiveness verification, escalation, and closure.
- Establish expectations for process-based, inspection-ready auditing that evaluates actual execution, system effectiveness, product impact, data integrity, and broader applicability.
- Determine when emerging risks require expanded audit scope, targeted assessments, for-cause audits, multi-site evaluation, or executive escalation.
- Build the predictive compliance intelligence capability, including its data strategy, analytical methods, technology roadmap, governance interfaces, talent model, and performance measures.
- Integrate audit data, inspection outcomes, regulatory trends, supplier performance, deviations, CAPAs, complaints, recalls, and other quality signals into a consolidated enterprise risk view.
- Develop predictive models, dashboards, early-warning indicators, and risk scenarios to guide audit priorities and proactive intervention.
- Identify systemic risks and recurring failure mechanisms across sites, suppliers, products, processes, and quality systems.
- Lead the technical capability strategy for auditors, including competency requirements, qualification standards, continuing education, and access to appropriate subject-matter expertise.
- Oversee AI-enabled audit and compliance intelligence tools.
- Ensure AI supports, but does not replace, qualified human judgment, accountable Quality decisions, audit independence, and objective evidence.
- Serve as a GMP/GDP advisor to the separate enterprise AI governance organization.
- Provide senior leadership with clear, actionable insight on emerging compliance risks and recommended interventions.
- Lead and develop a highly qualified, multidisciplinary global audit and compliance intelligence organization.
- Own the audit continuous-improvement roadmap and measures of audit effectiveness, not merely audit completion.

**Regulatory Compliance Collaboration**

The role will partner closely with:

- Regulatory Reporting and Inspection Readiness (RRIR) to apply audit and predictive intelligence to inspection readiness forums, pressure testing, mock inspections, inspection strategy, on-site inspection support, and response development for significant or multisite findings.
- Inspection Lifecycle Management (ILM) to integrate audit findings with inspection outcomes and lessons learned. ILM retains ownership of observation ratings, inspection scoring, and regulatory commitment tracking and closure.
- External Affairs to monitor emerging health-authority policy, enforcement priorities, and regulatory trends and translate them into audit, surveillance, and compliance priorities.

**Measures of Success**

- The global audit program demonstrates increased technical depth, challenge, consistency, and inspection relevance.
- Predictive compliance intelligence is established as a credible and actionable enterprise capability.
- The function identifies meaningful risks that would not have been detected through the routine audit program alone.
- Significant risks are identified before they result in major inspection, product, supply, or compliance events.
- Audit, inspection, commitment, supplier, quality, and external regulatory intelligence are integrated into a common enterprise risk view.
- Audit scope and priorities respond dynamically to predictive signals, inspection outcomes, supplier performance, and external regulatory trends.
- Audit intelligence strengthens RRIR inspection readiness and response strategy.
- ILM receives timely audit information to support inspection scoring, lessons learned, and commitment oversight.
- Recurring findings decrease, systemic issues are identified earlier, and corrective actions are sustainable.
- Auditor technical capability improves against defined competency standards.
- AI-enabled tools improve risk detection and audit effectiveness while maintaining human accountability and audit independence.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic leader we seek is an individual with these qualifications

**Basic Qualifications:**

- Doctorate degree and 5 years of biologics manufacturing and regulatory compliance experience OR
- Masters degree and 9 years of biologics manufacturing and regulatory compliance experience OR
- Bachelors degree and 11 years of biologics manufacturing and regulatory compliance experience

AND

In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Significant leadership experience in pharmaceutical or biotechnology Quality, auditing, compliance, manufacturing, regulatory affairs, analytics, or related disciplines.
- Demonstrated depth in Operations GMP/GDP compliance and the ability to independently evaluate complex manufacturing, laboratory, quality-system, supplier, and distribution risks.
- Experience leading a global audit, supplier-quality, inspection-readiness, quality-system, or compliance-intelligence organization.
- Demonstrated experience building or substantially transforming an enterprise capability, program, or operating model.
- Experience applying analytics, AI, or digital tools to compliance and risk management.
- Strong knowledge of global health-authority inspection expectations and enforcement trends.
- Demonstrated ability to identify emerging risk, make difficult compliance judgments, and influence enterprise decisions.
- Demonstrated ability to lead multidisciplinary teams and senior cross-functional stakeholders.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

District of Columbia

Senior Associate Quality Assurance

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Associate Quality Assurance**

**What you will do**

Lets do this! Lets change the world! The Sr. Associate Quality Assurance position supports Amgens Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements.

Duties include but are not limited to:

- Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments
- Electronic batch review
- GMP Document (SOPs/FORMs) revision review/approval,
- Review and approval of electronic Maintenance documentation Work Order/Job Plans.
- Quality support and approval of minor deviations,
- Electronic Batch Record (MES) documentation revisions and approvals
- Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.

Additionally:

- Must be flexible with shift work (including weekends) and comfortable with gowning requirements to support 24/7 production in a Grade 8 (Clean Room) Drug Product filling facility.
- Shifts may vary from 8hrs to 12hrs depending on rotation (Days, Swings, Graves)
- Shift rotations will be required (Days, Swings, Graves) to support production schedule

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek is an employee with these qualifications.

**Basic Qualifications:**

- High school/GED + 4 years of GMP experience OR
- Associates + 2 years of GMP experience OR
- Bachelors + 6 months of GMP experience OR
- Master's

**Preferred Qualifications:**

- Bachelors Degree in Biochemistry, Biology, Chemistry, or related science field
- Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
- Experience managing projects through to completion meeting timelines.
- Ability to evaluate documentation and operations according to company procedures.
- Experience working with Quality Systems
- Strong organizational skills and ability to manage multiple tasks at one time
- Effective communication skills (both written and verbal)
- Demonstrated ability to work as both a team player and independently
- Display leadership attributes and drive improvement initiatives
- Solid understanding and application of aseptic behaviors and principles

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

California

Novo Nordisk

Project Director, Quality Assurance - DPM Expansions

**About the Department**

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

What we offer you:

• Leading pay and annual performance bonus for all positions

• All employees enjoy generous paid time off including **14 paid holidays**

• Health Insurance, Dental Insurance, Vision Insurance – effective day one

• Guaranteed 8% 401K contribution plus individual company match option

• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave

• Free access to Novo Nordisk-marketed pharmaceutical products

• Tuition Assistance

• Life & Disability Insurance

• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Responsible for leading the Project QA organization to ensure fulfilment of project deliverables in accordance with the Novo Way while ensuring compliance with applicable regulations & the Novo Quality Management System.

**Relationships**

Reports to Senior Director, Quality.

**Essential Functions**

- Responsible for leading the Project QA team in accordance with the Novo Way
- Ensure compliance with applicable regulations & procedures
- Work within the frame of the Novo Quality Mission
- Provide performance management & leader standard work including setting short & long-term objectives & daily detailed planning & prioritization of work tasks
- Promote positive & effective collaboration with internal & external stakeholders
- Develop employees, to include driving high-performance behaviour & creating an environment for positive employee engagement
- Actively participate in Quality Leadership Team and Project Leadership Team activities, including strategy planning for the organization
- Ensure robust processes are in place to meet or exceed quality and business goals, project deliverables, organizational objectives & internal and external requirements
- Champion Continuous Improvement initiatives in the team
- Participate in regulatory inspections & internal audits as necessary
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned

**Physical Requirements**

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).

**Development Of People**

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business and that interim reviews are held so that their work is focused on those priorities and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures and Novo Nordisk Way.

**Qualifications**

- Bachelor's Degree in Life Sciences, Engineering, or related field from an accredited university required
- Minimum of five (5) years direct management experience required, preferably with experience leading high performing project teams. Minimum of five (5) years managing other managers preferred
- Minimum of ten (10) years of experience in a manufacturing organization managing projects, project teams or complex multi-level organizations required, preferably in a pharmaceutical manufacturing industry environment
- Experience with isolator technology & production of parenteral products preferred
- Demonstrated expertise & knowledge of US & EU regulations & guidelines, & application of GMP’s required
- Demonstrated knowledge of pharmaceutical quality systems (i.e., ICH Q10) preferred
- Excellent written & oral communication skills required
- Exercises excellent judgment in decision-making required
- CQA, CMQ/OE, &/or CQE certification preferred
- Project management skills preferred
- Demonstrated knowledge of cLEAN® preferred
- Proven expertise in mentoring & development, change management, planning & organizing, managing execution, & revising work plans for complex issues addressed by cross-functional teams required
- Ability to build strong working relationships within the team, with other departments & across other NN sites required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

North Carolina

Legend Biotech

Sr. Manager, QC Microbiology

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **Sr. Manager, QC Microbiology** as part of the **Quality** team based in **Raritan, NJ.**

**Role Overview**

The Sr. Manager, QC Microbiology, is an exempt level position with responsibilities for managing the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects. The role develops and implements long-term strategies and manages a team of people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities.

**Key Responsibilities**

- Ensuring adequate training (skills-based, cGMP and safety) of people leaders and associates within the department.
- Manage Raw material, in-process, environmental monitoring/utility, product release, and stability testing.
- Manage and support Investigation of laboratory non-conformances (events, deviations, and invalid assays).
- Maintenance, calibration and qualification of laboratory instruments and equipment.
- Test method verification, qualification, validation and/or transfer activities in the QC Micro laboratories.
- Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
- Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
- Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
- Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
- Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
- Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Monitor QC method performance through trending analysis for on QC generated test results.
- Represent department during internal and external audits.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
- Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
- Other duties will be assigned, as necessary.

**Requirements**

- A minimum of a Bachelor’s Degree in Science, Biology or equivalent technical discipline is required.
- A Minimum of 12 to 14 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in microbiology quality control laboratory, quality assurance, or cell therapy. A minimum of 3-5 years of leadership experience is also required.
- Experience working with Quality systems is required.
- Extensive knowledge of chemical, biochemical and microbiological concepts is required.
- Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- Comfortable with speaking and interacting with inspectors.
- Good written and verbal communication skills are required.
- This position may require up to 10% domestic or international travel as business demands.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
- Proven people management and leadership experience are required.
- In-depth knowledge and experience in biopharmaceutical analysis method verification is preferred.
- Experience in microbiological test methods and EM is preferred.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
- Proficient in applying excellence tools and methodologies.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Experience in developing and setting long-term objectives for individual and teams.
- Have a high sense of responsibility and professionalism with excellent organizational skills, analytical judgment and communication skills.
- Able to work cross functionally and under pressure.

\#Li-BZ1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$146,410 - $192,164 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

New Jersey

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Associate Quality Assurance**

**What you will do**

Lets do this. Lets change the world! The role is fully onsite in Thousand Oaks, CA, and requires the ability to lift 30+ pounds and pass a vision assessment for inspection work. Candidates must be comfortable working with raw materials and components, mainly chemicals, and may have to work in the sampling suite for extended periods of time. Previous experience with GMP is a plus but not mandatory, as training can be provided. Candidates of all backgrounds and experience levels will be considered if they demonstrate the right attitude and interest in the role.

**Key Responsibilities:**

- Responsible for sampling and inspection of raw materials and components
- Performing quality review of documentation for assigned functions (e.g. equipment and maintenance records).
- Lead small projects and continuous improvement initiatives.
- Operation and maintenance of instruments and equipment associated with sampling, e.g., Toledo balance, drum lift, pallet jack, etc.
- Maneuvering of large drums required.
- Responsible for the maintenance of training records, recording and computing data.
- Ability to maneuver 50+ pounds
- General understanding of aseptic techniques, cGMPs, gowning, sampling procedures and safety guidelines
- Work as a team player and/or independently
- Multi-task and basic problem-solving skills
- Excellent communication, both written and verbal
- Proficient computer skills (i.e. documentation systems, databases and spreadsheets).
- Strong attention to detail and effective time management skills

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with the following qualifications:

**Basic Qualifications:**

- High school/GED + 4 years of Quality experience OR
- Associates + 2 years of Quality experience OR
- Bachelors degree and 6 months of Quality or Operations experience
- Master's degree

**Preferred Qualifications:**

- Bachelors degree
- Prior GMP experience
- Previous experience using production/warehouse equipment
- Familiarity with inspection equipment

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Drug Product Quality Assurance Specialist

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Drug Product Quality Assurance Specialist**

**What you will do**

Lets do this. Lets change the world. In this vital role within the Plant Quality Assurance organization the Drug Product QA Specialist provides Quality oversight to operational activities associated with the aseptic Drug Product manufacturing and Inspection areas at Amgen, Thousand Oaks.

Under minimal supervision, the role ensures adherence to cGMP requirements, quality systems, and regulatory expectations while partnering closely with Manufacturing, Facilities & Engineering, and other cross-functional teams to support safe, compliant, and reliable operations. Primary responsibilities for this role include ensuring timely delivery and completion of records within our Quality Management System, including Deviations, Corrective Actions and Preventive Actions (CAPAs), Change Controls and document revision, review and approval. The QA Specialist partners closely with Manufacturing, Facilities & Engineering, Quality Control, and other cross-functional stakeholders to ensure events are thoroughly investigated, appropriately documented, and resolvedin accordance withregulatory requirements and site procedures.

The Quality Specialist will also evaluate compliance and operational issues, provide recommendations and oversight, and ensure the progress of quality records to completion. The individual will represent the B20 Quality function in projects as necessary to achieve departmental and plant goals and will work in a dynamic cross functional environment.

**Responsibilities:**

- Partners with Manufacturing, Facilities & Engineering, Quality Control, and other cross-functional stakeholders tofacilitateroot cause analyses, risk assessments, CAPAs, andeffectivenessverification activities.
- Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
- Partners with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
- Provides Quality Oversight of the manufacturing facility including manufacturing operations, inspection and utilities, as well as nonroutine activities such as process and product validation.
- Provides quality expertise and guidance to operational staff and within cross functional Amgen teams. Reviews and approves controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports.
- Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
- Participates in Amgen internal/external audits and inspections. Directly interacts with regulatory agencies during on-site inspections.
- Contributes to and drives continuous improvement projects in cross-functional collaboration. Represents the Quality function and provides quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
- Contributes to and drives digital innovation solutions and applications in cross-functional collaboration.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.

**Basic Qualifications:**

- Doctorate degree OR
- Masters degree and 2 years of quality experience OR
- Bachelors degree and 4 years of quality experience OR
- Associates degree and 8 years of quality experience OR
- High school diploma / GED and 10 years of quality experience

**Preferred Qualifications:**

- Bachelors Degree in Science
- 5 plus years of aseptic processing experience in QA or Manufacturing
- Strong experience supporting deviation investigations, root cause analysis, CAPA development, and Quality Management System processes such asChange Control and Risk Management
- Knowledge of contamination control strategies, environmental monitoring programs, and utility monitoring systems within GMP manufacturing environments
- Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partnersat all levels within the Organization
- Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality-minded conclusions
- Experience applying problem solving tools for root cause analysis.
- Experienceparticipatingin, managing, and responding to corporate audits/regulatory inspections
- Demonstrated ability with project management,initiatingand leading cross-functional teams, leading and managing change

**What you can expect from us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Afton Scientific LLC

Senior Facilities Maintenance Planner-Scheduler

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

- Serving clients in 18 Countries
- Successful NDA and ANDA drug registrations
- In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

**Position: Senior Facilities Maintenance Planner-Scheduler**

**Department:** Facilities

**Reports To:** Associate Director of Facilities, Maintenance & Utilities

**FLSA Status:**  Exempt

**Location:**  On-Site – Charlottesville, VA

Afton Scientific is seeking an experienced, highly organized, and results-oriented **Senior Facilities Maintenance Planner-Scheduler** to join our Facilities team. This position plays a critical role in ensuring the reliability and availability of our manufacturing equipment and utilities through effective maintenance planning, scheduling, and resource coordination.

The Senior Facilities Maintenance Planner-Scheduler will lead maintenance planning activities, help shape preventive maintenance and spare-parts strategies, and collaborate with Operations, Engineering, and Facilities to minimize equipment downtime and support uninterrupted manufacturing operations.

This is an excellent opportunity for an experienced maintenance professional who enjoys strategic planning, problem-solving, and driving operational improvements within a dynamic manufacturing environment.

**Compensation**

**$90,000 – $125,000 per year**

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

**Primary Responsibilities**

- Develop detailed maintenance plans for preventive, predictive, corrective, and shutdown maintenance activities.
- Review maintenance requests and convert approved work orders into executable work packages.
- Identify and coordinate required labor, materials, tools, equipment, permits, and contractor resources.
- Develop and maintain weekly, monthly, and annual maintenance schedules.
- Partner with Operations to coordinate maintenance activities while minimizing production disruptions.
- Prioritize maintenance activities based on safety, equipment reliability, regulatory requirements, and operational needs.
- Lead planning and scheduling for major plant shutdowns, turnarounds, and outages.
- Develop shutdown schedules, identify critical-path activities, and coordinate cross-functional planning meetings.
- Monitor maintenance schedules and implement recovery plans when necessary.
- Manage maintenance backlogs and ensure work orders are properly prioritized, planned, and completed.
- Maintain accurate planning and work-order information within the Computerized Maintenance Management System (CMMS).
- Support maintenance resource planning and critical spare-parts availability.
- Develop and monitor maintenance Key Performance Indicators (KPIs).
- Prepare weekly and monthly maintenance performance reports for management.
- Forecast future maintenance workloads and resource requirements.
- Ensure maintenance planning activities comply with company safety policies and applicable regulatory requirements.
- Support continuous improvement initiatives that strengthen equipment reliability, maintenance efficiency, and operational performance.

**Minimum Qualifications**

- Bachelor's degree in Engineering, Maintenance Management, Industrial Technology, or a related field; a technical diploma or equivalent experience may also be considered.
- **Minimum of eight years of maintenance planning and scheduling experience** in an industrial or manufacturing environment.
- Experience planning maintenance activities involving rotating equipment, electrical systems, instrumentation, utilities, or process equipment.
- Experience supporting major shutdowns, turnarounds, and maintenance projects.
- Strong knowledge of preventive and predictive maintenance programs.
- Understanding of maintenance workflows, equipment reliability, and maintenance planning practices.
- Strong organizational, analytical, and problem-solving skills.
- Effective written and verbal communication skills.
- Ability to manage multiple priorities and deadlines in a fast-paced manufacturing environment.

**Preferred Knowledge and Experience**

- Previous supervisory or leadership experience.
- Proficiency with Computerized Maintenance Management Systems (CMMS).
- Experience with spare-parts inventory management and maintenance-material planning.
- Experience working with single-use components used in pharmaceutical formulation, sterile filtration, and aseptic filling processes.
- Proficiency with Microsoft Office applications.
- Experience coordinating maintenance activities across multiple departments and external contractors.

**Key Competencies**

- Maintenance Planning & Scheduling
- Equipment Reliability
- Strategic Planning & Prioritization
- Cross-Functional Communication
- Resource Management
- Analytical Thinking & Problem Solving
- Safety & Regulatory Compliance
- Accountability & Follow-Through
- Continuous Improvement
- Leadership & Initiative

**What You'll Gain**

- The opportunity to play a leading role in strengthening Afton's maintenance planning and scheduling capabilities.
- Increased responsibility for maintenance strategy, equipment reliability, and operational efficiency.
- Experience coordinating complex maintenance projects, shutdowns, and equipment-related initiatives.
- Opportunities to influence maintenance processes, resource utilization, and performance measurement.
- Broad exposure to Facilities, Engineering, Operations, and other cross-functional teams.
- Continued professional development and opportunities for career growth within Afton Scientific.

**Physical & Work Requirements**

- Ability to work within office and manufacturing environments.
- Ability to occasionally stand, walk, sit, reach, and lift or move up to 40 pounds.
- Ability to perform extended computer-based planning, scheduling, and data-analysis activities.
- Regular on-site attendance is required.

Virginia

Eli Lilly and Company

Network Performance & Assurance Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**JOB POSITION OVERVIEW:**

The Network Performance & Assurance Lead sits within the Capital Portfolio Operations (PortOps) team in Global Facilities Delivery (GFD), part of Manufacturing & Quality, and reports to the AVP, Capital Portfolio Operations. This role supports an assigned network portfolio within GFD's capital delivery footprint (e.g., the API Dry Network, the Parenteral & Device Network, or another network as assigned by PortOps leadership) and is responsible for portfolio performance metrics, audit coordination, after-action reviews, and performance governance for that network's capital projects. The role coordinates GPCO controls standards, PMO resourcing, Operational Excellence & Governance processes, and Portfolio Comms support across the network's project teams. The role also confirms that projects in the assigned network are executing to GPCO-defined Project Controls standards, forecasts where Project Controls capacity is needed, conducts delivery assurance reviews, and reviews contractor and Managed Service Provider (MSP) cost data on the Owner's behalf. Network assignment is set by PortOps leadership and may change as GFD's network structure evolves. The role will be competent in each GFD standard process as it is introduced or revised, define what compliant execution looks like for project teams, and maintain process discipline across multiple senior stakeholders, influencing through others where it does not hold direct authority.

**RESPONSIBILITIES:**

Responsibilities are expressed as owned capability areas, applied to the network portfolio this role is assigned to support:

- Owns portfolio performance metrics for the assigned network's capital portfolio, including the reporting that feeds Project Unify dashboards for cost, schedule, and delivery performance across active projects in the network.

- Coordinates process audits and compliance reviews for the network's projects, including scheduling and follow-up on findings, in partnership with the function that executes the audit.

- Leads after-action reviews at project checkpoints and closeout and documents lessons learned for incorporation into GFD standard ways of working, in partnership with Operational Excellence & Governance.

- Coordinates support to network project teams across GPCO controls standards, PMO resourcing, Operational Excellence & Governance processes, and Portfolio Comms.

- Confirms that projects in the assigned network are executing to GPCO-defined Project Controls standards for cost, schedule, risk, and change management, and escalates deviations from those standards to GPCO.

- Forecasts Project Controls capacity needs across the network's portfolio and identifies coverage gaps before projects reach critical phases.

- Conducts delivery assurance reviews across the network's portfolio to identify where project controls processes are not being followed or where data is unreliable, and tracks corrective actions to closure.

- Reviews Managed Service Provider (contractor) cost data, invoices, and forecasts on the Owner's behalf before they are incorporated into network portfolio reporting.

- Owns performance governance for the network, including recurring portfolio performance reporting, participation in the network AVP's staff meetings (PALs), and continued development of Project Unify dashboards for the network AVP.

- Owns contract exhibit coordination for the network's capital projects.

- Establishes competency in each new or revised GFD standard process (PDWIs, SOPs, playbooks) ahead of network rollout, and serves as the network's reference point for correct application of that process.

- Trains and coaches network project teams on GFD standard processes, and provides feedback to Operational Excellence & Governance on process gaps identified during application.

- Maintains adherence to GFD standard processes across network projects, including with senior stakeholders, and escalates unresolved deviations to the AVP, Capital Portfolio Operations and the network AVP.

**BASIC QUALIFICATIONS:**

This position requires a combination of technical or project management education, direct experience delivering capital projects, and strong analytical and communication skills.

- Bachelor's degree in Engineering or a related field.

- 10+ years of experience in capital project delivery within industrial or manufacturing facilities, with experience in both project controls (cost, schedule, risk, or change management) and project management, and experience managing multiple senior stakeholders.
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1*

**PREFERRED QUALIFICATIONS:**

- Previous experience in pharmaceutical manufacturing or pharmaceutical capital project delivery.

- Demonstrated ability to influence decisions through others and maintain process discipline with senior stakeholders.

- Experience learning, applying, and training others on new processes or standards during organizational change.

- Proficient in portfolio performance reporting, audit coordination, governance forums, or continuous improvement work.

- Prior work with tools such as Smartsheet, Power BI, Oracle Unifier (PMIS), and Veeva Vault.

- Experience embedded with or supporting a Network AVP and staff, without daily on-site support from GPCO or PMO.

- Proven ability to operate effectively within GMP-regulated pharmaceutical environments.

- Lean Six Sigma or PMP certification.

**ADDITIONAL INFORMATION:**

- **Position Location:** Indianapolis, IN

- **Travel Percentage (%):** 30-50%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$118,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Sr. Principal Scientist - QA

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization Overview:**

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

**Position Description:**

The Sr. Principal Scientist - QA, is responsible for assuring and verifying QA responsibilities and expectations support for radioligand drug product manufacturing. The role provides Quality oversight during aseptic drug product manufacturing activities and performs final quality disposition of drug products for the Indianapolis Radioligand Therapies (IRLT) production site.

**Key Objectives/Deliverables:**

- Support the site to ensure a safe work environment including supporting safety efforts for the QA Ops team.
- Provide quality support of IRLT with a focus on holistic involvement in key activities including real time review of batch records on the floor, coverage during media fill, providing first line of support for quality escalations associated with or impacting the manufacturing processes and Quality Control operations.
- Ensure that documented in-process checks have been completed for batch disposition including but not limited to deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
- Complete disposition of Drug product batches and Drug substance Intermediates.
- Ensure regular presence in operational areas (preparation, formulation, synthesis, filling and visual inspection, AQL, QC, warehouse etc. areas) as a part of QA on the Floor support to ensure facility is compliant with GMP and inspection ready. Record compliance and inspection readiness observations per established local and global procedures.
- Plan and schedule tasks qualification and requalification activities.
- Provide training to floor QA and batch QA personnel as SME and qualified trainer for batch and floor QA tasks qualifications. Oversee execution of the same activities after training completion to provide feedback for sustaining compliance and development of the QA Ops organization.
- Provide technical/quality review of documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols, training documents, analytical method validations), as applicable.
- Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures.
- Drive operational excellence in floor operations and disposition process through data analysis to reduce variability and shift performance cycle times to align with supply delivery targets.
- Work cross-functionally with the area process teams for metrics reviews (e.g. deviation closure times, batch record release times, training completion etc.) to enhance operational support, and issue/deviation management.
- Assess and triage deviations in collaboration with the site process team.
- Lead, mentor, and coach operations and support personnel as quality SME during troubleshooting activities for manufacturing and QC operations.

**Minimum Requirements:**

- Bachelor's degree in science, engineering, computer, pharmaceutical-related field of study or related technical degree.
- 5+ years of experience in QA/QC roles in the pharmaceutical industry.
- On-site role (Indianapolis Radioligand Therapies)

- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1 B, TN, 0-1, E-3, H-181, or L-1

**Additional Skills/Preferences:**

- Ability to work independently and bring cross-functional team members together, and management as required, to manage potential failure modes, correct errors, remain organized and productive in a fast-paced joint team environment.
- Strong knowledge of Quality Management Systems and applicable regulatory requirements.
- Previous regulatory inspection readiness and inspection execution experience.
- Previous experience with Manufacturing Execution Systems and electronic batch release.
- Excellent interpersonal, written and oral communication skills.
- Previous experience working with radioligands preferred.

**Additional Information:**

- Tasks require entering manufacturing areas which require wearing appropriate PPE.
- Tasks require entering controlled areas where radioactive materials may be present. Special training and exposure monitoring are required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Senior Associate, Quality Assurance - QA for QC

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Position Overview:**

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Lilly Kenosha County (LKC). This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Senior Associate, Quality Assurance – QA for QC provides quality oversight, assistance, and guidance to the Quality Control Laboratories on issues such as non-conformance investigations, change controls, procedure revisions, method activities (e.g., transfers, verifications, validation), and commissioning and qualification activities. This position is essential for maintaining GMP compliance and ensuring inspection readiness.

**Responsibilities:**

- Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
- Leads, mentors, and coaches quality control laboratory personnel on quality matters.
- Supports the QA Compliance team and site in the execution of the site readiness plan with focus on right-first-time execution in the QC Laboratory.
- Reviews and approves laboratory instrument commissioning and qualification deliverables.
- Reviews and approves method deliverables including method transfers, verifications, and validations for QC Lab computer systems and equipment to ensure compliance with quality standards.
- Ensures regular presence in QC Lab areas to monitor GMP programs and quality systems.
- Serves as an active member on local lab team, as outlined in Lilly’s Manufacturing Standards for Operational Excellence, including participation with Lean Lab initiatives, daily huddle board and continuous improvement.
- Assess and triages deviations that occur within Quality Control.
- Works with Lilly support groups and external partners to resolve or provide advice on QC Lab related issues.
- Participates in self-led inspections and provides support during regulatory inspections.
- Works with the Global Quality Control laboratories and network personnel to benchmark and replicate best practices.
- Authors, reviews, and/or approves GMP documents in Quality Control to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls).
- Participates in continuous improvement projects to help improve productivity within the local process team or quality organization.

**Basic Requirements:**

- Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
- Minimum 5 years in the pharmaceutical industry with specific Quality Control experience.
- On-site presence required.

**Additional Skills/Preferences:**

- Demonstrated understanding of cGMP regulations.
- Previous experience in GMP production environments.
- Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing.
- Experience with LIMS, LES, SAP, Veeva QMS, Veeva Quality Docs.
- Proficiency with applicable laboratory management computer systems equivalent to MODA or LABVANTAGE.
- Demonstrated strong oral and written communication skills.
- Demonstrated interpersonal skills and the ability to work as a team.
- Root cause analysis/troubleshooting skills.
- Demonstrated attention to detail and ability to maintain quality systems.
- Proven ability to work independently or as part of a Team to resolve an issue.
- Technical Writing and Communication Skills.
- Previous regulatory inspection readiness and inspection execution experience.
- Computer System Quality Assurance (CSQA) experience or equivalent.
- Previous use of KNEAT – or equivalent electronic validation software.
- Previous facility or area start up experience.

**Additional Information:**

- Primary location is Kenosha County, Wisconsin
- Ability to travel (approximately 10 %)
- Ability to work overtime as required.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Wisconsin

Quality Assurance - Floor Support Specialist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Responsibilities**

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

**Position Overview:**

The Quality Assurance Floor Support Specialist (Night Shift) works as a member of the QA Floor Support team and reports to the Associate Director of QA Parenteral Operations. Responsibilities include providing QA oversight to GMP operations in the Parenteral equipment preparation, formulation, filling, and visual inspection areas. The QA Floor Support Specialist oversees production functions to achieve site goals while providing Quality oversight and ensuring compliance.

**Key Objectives/Deliverables:**

- Responsible for adhering to safety rules and maintaining a safe work environment for both ones-self and others by supporting HSE corporate and site goals.
- Responsible for ensuring training is completed and remains in compliance.
- Communicates with QA Process Team Leaders and AD of QA Parenteral Operations on quality and operational issues.
- Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
- Advise Operations and support personnel on quality matters, while driving the site Quality culture.
- Ensures regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems.
- Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance.
- Performs daily documented Quality Checks.
- Perform sample collection, inspection, and delivery of samples to storage location and/or laboratory.
- Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise. PMX, Master Control, and Veeva).
- Participate in self-led inspections and provide support during internal / external regulatory inspections.
- Ability to work cross functionally and work collaboratively with all levels of the organization.
- This is a 12Hr Night shift position 2-2-3 schedule.

**Basic Qualifications**

- High School Diploma or equivalent
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Completion of Post Offer Exam or Completion of Work Simulation if applicable.
- Ability to work overtime, as requested.
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1*

**Additional Skills/ Preferences**

- Demonstrated strong oral and written communication and interpersonal skills.
- Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
- Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.
- Knowledgeable with inventory management systems and deviations systems, (i.e. SAP, TrackWise, etc.)
- Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
- Previous experience in GMP production environments.
- Previous facility or area start up experience.
- Knowledge of Validation / Qualification activities.
- Demonstrated decision making and problem-solving skills.
- Strong attention to detail
- Proven ability to work independently or as part of a team to resolve issues.

**Additional Information**

- May be required to respond to operational issues outside of core business hours / days.
- Applicant may work in various areas within the DAP and Warehouse buildings. Mobility requirements should be considered when applying for this position.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$18.75 - $35.96

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Senior Manager of Quality Assurance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Position Overview**

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Position Description**

Sr. Manager Quality Assurance (QA) Parenteral is responsible for the staffing, training, and leadership of the quality assurance group supporting the project/expansion delivery, process development, operational readiness, start up, and validation/qualification of the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection. The Sr. Manager will help build a strong quality culture and lead the QA team for oversight and support of the ongoing operation as well as site inspection readiness and execution.

On Site Shift Schedule: Monday to Friday 4pm to 12:30am Subject to change as needed

Direct Reports: Night shift team 6pm to 6am

**Key Objectives / Deliverables**

· The Night Shift Sr. Manager, Quality Assurance, will support the start-up and routine operation of the QA organization overseeing Parenteral operations at Lilly's Kenosha, Wisconsin pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as project management.

· Serve as technical resource to review and approve technical documents

· Network with cross-functional technical project delivery team to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework

· Work with the Associate Director, Quality Assurance to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on the formulation, filling and visual inspection programs

· Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production

· Manage a team of up to approximately 8-12 direct reports

· Support the site to ensure a safe work environment including supporting and leading safety efforts for your team

· Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls

· Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group

· Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment

· Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.

· Network with global and other parenteral sites to understand best practices and share knowledge

· Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management

· Support inspection readiness activities

· Interact with regulatory agencies during inspections regarding cGMP issues

· Ensure data integrity by design

**Requirements (Education, Experience, Training):**

- Bachelor's degree in a science, engineering, or related field of study

· 5+ years in pharmaceutical leadership including leading or working effectively with a cross-functional group

- Excellent interpersonal, written and oral communication skills

- Strong technical aptitude and ability to train and mentor others

· Ability to work overtime as required

· Ability to travel 10-25% to other Lilly sites for training/meetings

· May be required to respond to operational issues outside of core business hours and days

**Preferred attributes but not required:**

· Commit to successfully maintain Lilly Computer System Quality Assurance (CSQA) Certification

· Strong knowledge of Quality Management Systems and applicable regulatory requirements

· Previous experience directly supporting a pharmaceutical manufacturing operation

· Excellent interpersonal, written and oral communication skills

· Strong technical aptitude and ability to train and mentor others

· Demonstrated technical writing skills

· Demonstrated problem-solving and decision-making skills

· Previous facility or area start up experience

· Previous equipment qualification and process validation experience

· Previous experience with highly automated syringe filling, vial filling, and visual inspection equipment

· Previous experience with Manufacturing Execution Systems and electronic batch release

· CQM, CQE, or CQA certification from the American Society for Quality (ASQ)

· Previous experience with deviation and change management systems including Trackwise, MasterConrrol, and Veeva

**Additional Information**

This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$97,500 - $143,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Senior/Principal QA Associate - Cell & Gene Therapies, External Manufacturing

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

The Lebanon Advanced Therapies (LP2) Quality Assurance External Manufacturing Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination.

LP2 External Manufacturing Quality Assurance maintains communication and working relationships with alliance partners, contract manufacturers, and internal customers. The External Manufacturing QA Representative manages daily contract manufacturing activities and ensures adherence to Lilly GQS and cGMPs through deviation investigations, change control, documentation management, validations, and other relevant responsibilities. This position also supports inspection readiness, product launches, and is accountable for batch disposition, confirming all batches comply with specifications and regulatory requirements.

**Responsibilities:**

- Serve as a liaison between CMs and Lilly, providing quality oversight and serving as the initial point of contact for all quality-related issues
- Escalate quality issues at CMs to Lilly QA management.
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs)
- Evaluate and disposition drug substance, drug product, and packaging batches ensuring that documented checks have been completed for the Certificates of Testing, Certificates of Environmental Monitoring (where applicable), deviations, changes and batch documentation
- Provide quality support of manufacturing operations with holistic review of key activities associated with or impacting the manufacturing processes.
- Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product
- Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations
- Provide onsite support of manufacturing operations as required
- Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections
- Participate in APR activities
- Participate in Post Launch Optimization Teams (PLOT)

**Basic Requirements:**

- Bachelor's degree in relevant field (preference for scientific or engineering field).
- 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.
- Previous experience providing Quality Assurance oversight of contract manufacturers.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
- ASQ Certified
- Previous facility or area start up experience
- Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging
- Previous experience with Manufacturing Execution Systems.
- Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills
- Demonstrated strong problem solving and decision-making skills
- Previous technical writing experience
- Technical aptitude and ability to train and mentor others

**Additional Information:**

- Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office
- Position may require travel (10-25%)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Lilly Medicine Foundry – Senior Technical Lead – Quality Systems, Automation & AI

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

**What You’ll Be Doing:**

As a Senior Technical Leader at the Lilly Medicine Foundry, you will serve as both a hands-on technical practitioner and the functional lead for service management, test automation, technology and business quality process automation, GMP readiness, compliance and AI enablement. This role sits at the intersection of systems configuration, GxP compliance, and operational collaboration requiring someone who can drive alignment across Technology at Lilly, process science, engineering, operations, and quality stakeholders.

At the Lilly Medicine Foundry, you will be the key technical resource for the quality systems and processes for Technology at Lilly and the business. In addition, you will prototype, evaluate and implement emerging AI/ML and generative AI use cases relevant to quality process automation, documentation, and similar workflows.

You will be instrumental in delivering IT automation and AI solutions that meet stringent quality standards and facilitate the site’s mission and vision.

**Key responsibilities include:**

- Own the technical roadmap and architecture standards for the digital transformation and Quality process automation at Medicine Foundry.
- Expanding subject matter expertise in core systems including Digital Forms, Global QMS system(s), and Global Quality AI and Analytics solutions, partnering with Global and PRD Quality teams.
- Leading test automation strategy and owning CI/CD automated pipelines and automated code management practices, leveraging tools such as JIRA, ALM, and GitHub.
- Driving digital innovation into the Business Quality space through the adoption and implementation of Global and local Quality AI and automation efforts
- Soliciting and coordinating innovation across Technology at Lilly teams operating in the Quality space, including cross-functional engagements primarily across CTI and M&Q

**How You Will Succeed:**

- Establish yourself as the go-to technical authority for digital solutions across the Business Quality space, shaping architecture, design, and implementation decisions.
- Build and continuously expand SME-level knowledge of Digital Forms, Global QMS system(s), and Global Quality AI and Analytics solutions, partnering closely with Global and PRD Quality teams.
- Champion test automation and robust CI/CD pipeline practices, ensuring reliable, well-governed automated code management across JIRA, ALM, GitHub, and related tooling.
- Proactively solicit innovation ideas and collaboration opportunities across Technology at Lilly teams operating in the Quality space, forging cross-functional partnerships across CTI and M&Q.
- Communicate technical strategy and solution roadmaps clearly to both technical and business stakeholders, building consensus and trust.
- Anticipate emerging risks and opportunities in the digital quality landscape, escalating and resolving issues proactively with Global and PRD Quality partners.
- Stay current on trends and innovation in quality technology and AI by engaging with external forums, conferences, and internal communities of practice.

**What You Should Bring**

- Demonstrated technical leadership experience across digital quality systems, ideally including Digital Forms, Global QMS platforms, and Quality AI/Analytics solutions in a regulated environment.
- Hands-on expertise with test automation frameworks, CI/CD pipeline design, and automated code management using tools such as JIRA, ALM, and GitHub.
- Experience driving digital innovation initiatives, including AI-enabled solutions, within a Quality or GxP-regulated business function.
- Strong collaboration skills with a track record of partnering across global and cross-functional teams (e.g., Global/PRD Quality, Clinical, Technology at Lilly) to advance shared innovation goals.
- Ability to solicit, evaluate, and champion innovative ideas across a broad technical community, translating them into scoped digital initiatives.
- Solid understanding of GxP/quality compliance requirements as they apply to digital solutions and automation.
- Excellent communication skills, with the ability to translate complex technical concepts for both technical and non-technical audiences.
- Comfort operating in an evolving, fast-paced environment, managing multiple concurrent priorities and driving initiatives from concept to delivery.

**Basic Qualifications:**

- Bachelor’s degree
- Minimum of 5+ years of experience in quality, validation, or technology roles supporting GMP-regulated systems, with exposure to manufacturing or laboratory operations.
- Minimum of 4+ years of experience supporting or leading Computer System Validation (CSV) or Computer Software Assurance (CSA) activities in a GMP-regulated environment (GMP, GLP, or GCP).

**Preferred Qualifications:**

- Experience working within or alongside a pharmaceutical manufacturing operation.

**Other Information:**

- Initial location will be based out of Indianapolis, Indiana.
- Permanent location will be at the new Lilly Medicines Foundry in Lebanon, Indiana.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$129,000 - $231,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Quality Assurance Operational Support

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.

**Position Overview:**

The Quality Assurance Operational Support Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide oversight for the delivery and daily operation of the Lilly Advanced Therapies (LP2) site. The QA Operational Support Representative provides guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. The Quality Assurance Operational Support Representative is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.

**Responsibilities:**

- Adhere to safety rules and maintaining a safe work environment for both you and others by supporting HSE corporate and site goals
- Provide technical and quality review and approval of documents to ensure compliance with Lilly Global Quality Standards and local procedures
- Oversee verification of manufacturing equipment/facilities from definition of requirements thru design and testing

- Lead, mentor, and coach operations and support personnel on quality matters, e.g. good documentation practices, data integrity and regulatory compliance.
- Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
- Support the definition and execution of inspection readiness activities and provide support for internal / external regulatory inspections
- Lead/support Process Team initiatives needed in support of the Site and Quality function
- Ensure regular presence in operational areas to monitor GMP programs and quality systems
- Provide guidance and triage for deviations and change controls
- Support and/or execute review of batch records and release of drug substance, drug product, and finished product batches for Clinical Trial and commercial use
- Consult with Network and Global quality groups as required to ensure consistent and compliant approach to facility delivery and operation

**Basic Requirements:**

- Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.

- 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Skills/Preferences:**

- Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
- Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills
- Demonstrated strong problem solving and decision-making skills
- Previous technical writing experience
- Technical aptitude and ability to train and mentor others
- ASQ Certified
- Experience with equipment verification and validation oversight including automation and computer systems validation.
- Previous facility or area start up experience.
- Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging.
- Proficiency with computer systems including Kneat, Veeva Vault, SAP, manufacturing execution systems, and Microsoft Office products.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Dren Bio

Director of Clinical QA

Director of Clinical QA

About the Company:

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. In addition, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Importantly, multispecific antibodies generated from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies. For more information, please visit our website at www.drenbio.com.

Function:

Quality

Level:

Director

Location:

San Carlos, CA (Remote candidates may be considered)

Reporting Manager:

VP of Quality

About the Opportunity:

This critical position will collaborate with internal clinical and nonclinical functional groups and external parties including consultants, contract auditors, CRO/Service Provider personnel, and Investigator Sites to promote a high level of quality and consistency across all Dren development programs. This includes a risk-based approach to Quality Management for all Dren programs. Additionally, this position will independently manage domestic and international risk-based audits of Investigator Sites, clinical vendors, study databases, partners or collaborators (as applicable). The Director of CQA will also support internal Dren quality systems with the creation, review, and adherence to company policies, and procedures and adhering to GxP requirements.

Role and Responsibilities:

- Provide leadership and support for Inspection Readiness activities and initiatives,and for the preparation, conduct, and response periods of Regulatory AuthorityInspections.
- Maintain expert up-to-date knowledge on applicable regulations that govern theconduct of clinical trials, ICH GCP guidelines and other GxP regulations andindustry guidance and ensure the information is integrated into Quality and Clinicalprocesses.
- Support the development and maintenance of CQA controlled documents and proceduresthat comply with ICH GCP standards and applicable regulations.
- Create and execute annual audit plan to ensure GCP compliance and adherence to studyprotocols by vendors, Investigator sites, study databases, and internal clinicalteam.
- Author and/or review procedures to support the Quality Management System, with anemphasis on clinical quality processes, clinical operations and clinical developmentfunctions.
- Collaborate with clinical functional groups (e.g., Clinical Operations, DataManagement, etc.) to provide GCP and regulatory compliance support at the studyexecution level. This includes Clinical Study Execution Team (CSET) membership andparticipation.
- Perform review of clinical trial documents with a focus on compliance, regulatoryrequirements, and risk (study and company levels). The study documents include butare not limited to: Study Protocol and amendments, ICFs, Investigator’s Brochure,Annual Reports (e.g., DSUR), CSRs, and other study level documents (e.g., studyplans, subject recruitment materials).
- Conduct gap analyses and risk assessments for critical study level activities thatmay impact subject safety and/or the quality and reliability of data.
- Lead or support audits and investigations to evaluate non-compliance, root causeidentification, and report results to Dren management. Ensures timely completion ofcomprehensive reports and communication of observations to auditees, impactedfunctional groups, and Dren management.
- Ensures audit corrective and preventive action (CAPA) plans adequately address auditobservations and identified root causes, including effectiveness checks whereappropriate.
- Escalate compliance issues to QA Management and other relevant leadership as neededin a timely manner.
- Develop, and/or support GxP tasks or Continuous Improvement initiatives as needed.
- Manage the workflow of CQA consultant Auditor(s), and as applicable, manage juniorCQA staff.
- Build positive professional relationships to support learning, open communication,collaboration, and teamwork.

Education, Experience and Qualification Requirements:

- Minimum of a Bachelor of Science (B.S.) degree in a scientific, life science, ormedical/technical discipline.
- Minimum of 10 years’ experience within the pharmaceutical industry with at least 8years of experience in a GCP or CQA quality role, with increasing levels ofresponsibility.
- Minimum of 5 years’ experience in leading or independently performing CQA audits(Vendor qualification/routine/for-cause, Investigator Site, Gap Assessment, TMF,CSR, etc.), and audit CAPA management.

Core Competencies, Knowledge and Skill Requirements:

- Experience with BIMO inspection, training and preparing company and study sites forinspection readiness
- Knowledge of Computer System Validation requirements in association with CQA audits.
- Effective communication skills (written and verbal).
- Ability to build and sustain positive relationships with colleagues, internalstakeholders, and external partners by being transparent, reliable, and deliveringon commitments.
- Demonstrated ability to influence areas not under direct control to achieveobjectives and effectively communicate challenging goals and objectives.
- Ability to create innovative solutions to problems, while integrating stakeholderinput and feedback.
- Ability to manage multiple priorities and aggressive timelines.
- Highly responsible, self-motivated professional with enthusiasm and passion for thecompany's mission.
- Proficient with various Microsoft and other computerized tools: MS Word, Outlook,Excel, PowerPoint, etc.
- Expert knowledge in ICH GCP guidelines and FDA regulations

Salaries, Benefits and Other Employee Perks:

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company’s total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $190,000 and $225,000 per year. At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio’s Human Resources department can share more about the specific pay range based on the market location of the candidate.

Employment Practices:

Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.

Associate, Quality Assurance, Manufacturing Operations, Lilly Medicine Foundry

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Organization and Position Overview**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

As the Foundry is currently in design and construction (startup phase anticipated completion in 2027), the initial position will be fluid and dynamic as we endeavor to support the delivery of the Foundry, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing facility.

Once start up activities are completed, the Quality Assurance Associate, Manufacturing Operations role will perform manufacturing production floor QA support functions which includes day to day Quality oversight of GMP operations, change management and investigation reviews as well as other activities, as assigned.

**Responsibilities**

- Participate in creating and maintaining a safe work environment.
- Foster a strong collaborative quality culture including maintaining open communication and promoting teamwork and employee participation in the work group and with cross-functional teams.
- Ensure compliance with applicable laws, regulations, and guidelines to support GMP activities.
- Review GMP documentation including procedures, deviations, technical reports, change controls, etc.
- Work cross-functionally with the plant teams to provide operational support, and issue management.
- Assist with inspection readiness activities.
- Effectively communicate with internal and external stakeholders.

**Basic Requirements:**

- BA/BS degree in Engineering, Science, or other related field and a minimum of 2 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry
- Understand GMP requirements for early phase development and manufacturing and in application of quality management systems.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Effective project and time management skills.
- Demonstrated ability to prioritize and handle multiple concurrent tasks.
- Cognitive abilities, which include problem solving, verbal reasoning, attention detail, critical thinking and analytical competencies.
- Demonstrated strong oral and written communication skills.
- Effective organization/self-management skills
- Demonstrated relevant experience in a cGMP facility.
- Relevant industry experience in high paced working environment.
- Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills.
- Flexibility to adjust quickly and effectively to frequent changes and altered priorities.
- Ability to identify and prioritize issues and develop & implement solutions.
- High learning agility and ability to deal with ambiguity, uncertainty.
- Demonstrated attention to detail.

**Other Information:**

- Position Location - Initial location: Indianapolis, IN US; Future: Lebanon IN Lilly Medicine Foundry Operations
- Travel Percentage: 5% - 15%
- May be required to provide on-call support outside of normal working hours including nights, weekends, and holidays.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

\#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Quality Assurance- Business Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Position Brand Description:**

The role of the Quality Assurance- Business Development is to support activities related to business development initiatives for asset and company acquisitions as well as licensing deals. The individual will complete risk assessments related to acquisitions and ensure appropriate risk mitigation is employed. This role will work with the Senior Director QA Business Development to ensure a robust strategy and integration plan is developed and executed for each acquisition. This individual will represent Quality on strategic projects related to acquisitions and may also support due diligence activities as needed.

**Key Objectives/Deliverables:**

**Acquisitions**

- Partner with business leads to identify risks, mitigations and develop a risk appropriate strategy and transition plan for acquisitions.
- Partner with Quality and key business leads at acquired company to communicate PRD strategy and transition plan and work to ensure a smooth transition for Quality-related items.
- Work with cross functional team in PRD to deliver portfolio needs and manage Quality-related issues as they arise
- Provide coaching and education to the business and Quality organization on quality requirements for the Acquisition process.
- Support the authoring, negotiation, and implementation of Quality Agreements as needed.
- Author Integration Strategy documents, risk assessments, and change controls as needed.

**General**

- Coordinate activities with PRD Quality Management and Quality resources to ensure timely execution of GMP activities for acquisitions.

**Basic Requirements:**

- Bachelor’s Degree
- Minimum of 10 years of Quality Assurance or related experience.
- Minimum 2 years’ experience in PR&D (business or QA)
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Project Management knowledge/experience
- Experience working with external parties
- Demonstrated leadership skills
- Demonstrated strong written and verbal communication skills
- Demonstrated ability to work in high pressure situations on tight timelines.
- Demonstrated ability to work independently and in a highly integrated team environment
- Demonstrated ability to coach and mentor others

**Other Information:**

- Up to 10% travel may be required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$101,250 - $184,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Associate Director, Commercial Controls & Cost Assurance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global Facilities Delivery (GFD) Organization delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

**Position Summary**

The Associate Director, Commercial Controls & Cost Assurance serves as GFD's enterprise process owner for capital invoice management, payment assurance, forecast validation, and earned value management. The role is accountable for the governance, standardization, and continuous improvement of the processes, systems, standards, controls, and performance measures that support financial stewardship and project performance across the global capital portfolio. Serving as the primary interface between the Invoice Management Office (IMO) and Project Controls organizations, the incumbent owns GFD's earned value methodology, Rules of Credit, and associated governance frameworks while driving consistent execution through KPI-based performance management and assurance.

**Key Responsibilities**

- Own and continuously improve GFD's capital invoice management, payment assurance, earned value management (EVM), Rules of Credit, and associated standards, procedures, controls, and governance frameworks.

- Serve as GFD's enterprise authority for invoice validation, earned value performance, forecast quality, cost assurance, and payment compliance determinations.

- Define, govern, and maintain business requirements, data standards, workflows, and change control processes supporting invoice management, payment assurance, forecast validation, and earned value performance.

- Partner with Engineering Systems & Tools, Finance, Procurement, and other stakeholders to define requirements, support testing activities, and prioritize system and process enhancements.

- Act as the primary interface between the Invoice Management Office (IMO), Project Controls teams, and other business stakeholders to resolve operational issues, strengthen process performance, and escalate significant risks or concerns.

- Lead cost assurance activities, including invoice validation, forecast quality reviews, compliance assessments, payment assurance controls, and performance monitoring.

- Ensure compliance with established financial controls, contractual payment requirements, governance standards, and project controls procedures.

- Establish, monitor, and report KPIs related to invoice management, forecast performance, earned value performance, process compliance, operational effectiveness, and continuous improvement.

- Collaborate with Capital Procurement, Finance, and Legal to develop and maintain contract language, commercial exhibits, payment requirements, and supporting governance procedures.

- Develop training materials, work instructions, job aids, and onboarding resources to ensure consistent adoption and execution of invoice management, payment assurance, cost assurance, and earned value management processes across the GFD portfolio.

**Minimum Requirements**

- Bachelor’s degree in business management, finance, engineering, construction, or related field, or equivalent work experience.

- At least 8 years of experience in project control, quantity surveying, or similar field.

- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1*

**Preferred Requirements**

- Professional certification in cost engineering, project controls, project management, or quantity surveying (e.g., AACE CCP, EVP, PSP; PMI-PMP, PMI-SP, PMI-CP; MRICS/FRICS).

- Experience leading EVM, Rules of Credit, cost assurance, contractor payment validation, and capital invoice management processes on major capital projects.

- Experience with shared service functions such as Procure-to-Pay (P2P), Source-to-Pay (S2P), Accounts Payable, or Invoice Management Offices.

- Proficiency with enterprise ERP, P2P and/or PMIS platforms that support capital invoice management, payment assurance, cost management, forecasting, earned value management, reporting, and performance governance.

- Strong knowledge of capital project contracts, payment application processes, Schedules of Value, contractor billing, audit controls, forecasting, and commercial risk management.

- Strong analytical, communication, and stakeholder management skills, with the ability to drive enterprise standards, governance, and continuous improvement.

**Additional Information**

- Required to be based in Indianapolis, Indiana.

- Willingness and ability to travel up to 25%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$118,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Associate Director - Central Engineering and Maintenance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Responsibilities:**

The Associate Director of Central Engineering & Maintenance is responsible to provide technical and administrative coordination for Lilly site electrical engineering, commissioning and qualification, capital projects, calibration, and maintenance planning services. The role will have the site electrical engineer, commissioning and qualification engineer, CAPEX team, calibration team, and maintenance planning team as direct reports. The role will report to the Sr. Director – Engineering Concord.

**Key Objectives/Deliverables:**

- Provide technical and administrative oversight for site electrical engineering. This includes power distribution, UPS and emergency power systems, and the site electrical safety program (e.g. NFPA 70E, arc flash) in partnership with HSE.

- Provide technical and administrative oversight for the site commissioning and qualification program. This includes the transition from project to site ownership (e.g. qualification) and ongoing sustainment (maintaining in qualified state), including periodic reviews and Asset Qualification Monitoring (AQM).

- Lead the site capital portfolio from scoping and funding through execution, handover to operations, and close-out. Own capital budget, forecast accuracy, and delivery of projects on scope, schedule, and budget.

- Provide technical and administrative oversight for the site calibration program, including schedule compliance, traceability, and ongoing compliance with internal standards (e.g. LQS, GQS) and external regulatory requirements. Lead out-of-tolerance investigations and product impact assessments.

- Provide technical and administrative oversight for site maintenance planning and scheduling. This includes work order planning, CMMS data integrity, backlog management, PM optimization, and shutdown planning in partnership with Operations.

- Provide technical and administrative oversight for any changes or deviations in electrical engineering, commissioning and qualification, capital projects, calibration, and maintenance planning. Conduct robust root cause investigations ensuring appropriate CAPA.

- Lead, coach, and develop direct reports, including talent planning, performance management, and succession.

- Ensure practice matches procedure

- Champion continuous improvement

- Represent central engineering and maintenance capabilities beyond the Lilly Concord site (e.g. other Lilly sites and global functional groups).

- Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.

**Basic Qualifications:**

- Education Requirements: Bachelor’s degree in Engineering

- At least 5 years engineering and/or maintenance experience in a manufacturing site
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

**Additional Skills/Preferences:**

- Site start up experience preferred

- Solid understanding of basic requirements of regulatory agencies

- Previous people leadership experience, including leading multi-disciplinary teams

- Previous experience in operations and engineering

- Previous experience with highly automated equipment

- Previous equipment qualification and process validation experience

- Previous experience with deviation and change management systems including Trackwise

- Experience with calibration programs and maintenance planning in a CMMS (e.g. SAP)

- Experience managing capital projects

- Ability to handle multiple competing priorities

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$123,000 - $180,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly