Quality

BioMarin Pharmaceutical Inc.

Director, Quality Data Governance & Technology

:

The Director Quality, Data Governance & Technology is a senior Quality leadership role accountable for enterprise-wide Quality oversight of Computer System Validation (CSV) activities across BioMarin’s IT systems and applications, and for owning and continuously improving the CSV program in collaboration with the DTA (Digital Technology and AI) team. This role is equally accountable for leading BioMarin’s Data Governance and Data Integrity program, driving the design, effectiveness, and continuous improvement of data governance measures, global compliance and process performance.

Cross-functional collaboration with partners and stakeholders across sites and functions is key to success in this role. This includes close partnership with data experts and stakeholders across engineering, computer system validation, manufacturing, data sciences, QC, QA, Compliance, and DTA. In collaboration with these SMEs and stakeholders, the Director ensures that all processes impacting computer software validation, data governance, and data integrity are compliant, agile, and support the evolving needs of the business.

This role is also a driving force behind BioMarin’s digital and AI advancement within Quality. The Director partners with DTA, Data Science, and business stakeholders to identify, evaluate, and scale emerging technologies, including AI, machine learning, automation, and advanced analytics, ensuring BioMarin remains at the forefront of regulatory expectations while unlocking potential across the Quality organization. This is an exciting time to step into this role, as AI rapidly reshapes how Quality Processes can operate, the Director will have the opportunity to shape how BioMarin harnesses these technologies responsibly, positioning the organization at the leading edge of this transformation.

This position requires in-depth knowledge and experience with computer system validation, data governance, and data integrity, along with a high-level understanding of other quality management system processes. The leader must possess strong leadership qualities, business acumen, and technical expertise in the areas of responsibility, together with a solid understanding of developments in data science and emerging technologies such as AI, machine learning, and cloud computing, to address complex challenges in a pharmaceutical environment.

**RESPONSIBILITIES:**

**Computer System Validation (CSV) Quality Oversight & Program Leadership**

- Provide leadership and direction to a team of Quality Engineers responsible for Quality oversight of computer software validation activities for enterprise-wide systems and applications. Ensure appropriate resource support to manage established portfolio of projects.
- Co-lead continuous improvement of the CSV program, standardizing methodologies, requirements, and lifecycle approach within a harmonized and simplified QMS environment.
- Evolve the CSV program's execution model to be ready for a future where AI plays an increasing role in system validation, reassessing methodologies, controls, and resourcing so the program can efficiently and compliantly validate AI-enabled systems and leverage AI-assisted validation tools as they mature.
- Ensure CSV/CSA activities are interconnected, aligned, and streamlined with policies and procedures established by DTA and CSV, applying a System Development Lifecycle approach commensurate with system complexity, risk, and intended use.
- Establish global KPIs and oversee trending of key performance metrics associated with the CSV program; support Quality Management Review activities; report and escalate compliance issues to management.
- Partner with Compliance on site and global Quality inspections, providing SME support related to CSV activities and related observation responses.

**Data Governance & Data Integrity Program Leadership**

- Develop, own, and continuously improve a comprehensive and compliant Data Governance / Data Integrity program for BioMarin, accountable for its design and overall effectiveness.
- Implement the data governance framework under a Data Governance Master Plan, in collaboration with cross-functional teams including IT, manufacturing, technical development, quality assurance, and R&D; align and gain sponsorship from leadership and stakeholders.
- Define deliverables for the implementation of enhanced data governance measures to enable data integrity assurance by-design, ensuring solutions are purposefully integrated into business processes to drive adoption.
- Optimize policies, procedures, and programs for data governance and data integrity, standardizing methodologies and requirements within a harmonized and simplified QMS environment.
- Implement and maintain a training program for data governance / data integrity across BioMarin.
- Establish and lead a governance structure, partnering with a matrix team of site and functional representatives accountable for establishing, owning, and continuously improving data governance processes within their respective areas.

Establish global KPIs and oversee trending of key performance metrics associated with the data governance / data integrity program; support Quality Management Review activities; report and escalate compliance issues to management.

**Digital Transformation, Data & Artificial Intelligence**

- Support the establishment of BioMarin’s digital and AI strategy for Quality, ensuring the organization is at the forefront of regulatory expectations, guidance, and standards applicable to emerging technologies.
- Partner with IT, Data Science teams, and other stakeholders to identify, evaluate, and pilot future technologies, including AI, machine learning, automation, and advanced analytics, to support strategic Quality and business objectives.
- Drive the effective use of Quality data by integrating information from QMS and other enterprise systems to generate actionable insights and enable data-driven decision-making.

Champion the responsible piloting and scaled deployment of AI-enabled tools within Quality, ensuring appropriate governance, human-in-the-loop controls, and evidence-based, measurable KPIs guide go / no-go decisions.

**Cross-Functional & Network Collaboration**

- Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes.
- Collaborate with data experts and stakeholders across engineering, manufacturing, data sciences, QC, QA, Compliance, and IT to ensure processes remain compliant, agile, and aligned to business needs.

As needed, partner with Compliance on site Quality inspections with the goal of regulatory compliance and site harmonization; provide SME support to site and global inspections and related observation responses.

**Leadership, Talent & Organization Development**

- Lead, coach, and develop a high-performing team of Quality Engineers, building capability in CSV, data governance, and digital / AI competencies.
- Foster a culture of continuous improvement, compliance, and innovation across the CSV and data governance functions.
- Drive a consistent, standardized approach to CSV and data governance across the global network while enabling flexibility where required.

**EDUCATION:**

- Bachelor’s or advanced degree (preferred) in Data Science, Computer Science, Engineering (Chemical Engineering, Biotechnology, or a related field), or Life Sciences.

**EXPERIENCE:**

- 15+ years of experience in Biotechnology, Pharmaceutical, Medical Device, or another highly regulated industry.
- Extensive knowledge and experience with GMP and GDP global regulations, principles, concepts, practices, and standards.
- Strong knowledge of computer system validation, data integrity, data governance, and related processes.
- 8+ years of prior management-level experience with a demonstrated ability to develop and mentor staff.
- Demonstrated experience using data, analytics, and digital tools to improve quality outcomes; experience with AI-enabled solutions is a strong plus.
- Strong communication and stakeholder management skills, with experience driving cross-functional initiatives.
- In-depth experience managing teams, and providing coaching, development, and mentoring to employees.
- Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
- Excellent interpersonal and communication skills, with the ability to influence diverse stakeholders and drive accountability and decision-making cross-functionally.
- Ability to present data and defend approaches in front of senior management and inspectors.
- Demonstrated ability to partner with other functional groups.

**WORKSTYLE:**

- Preference for the individual to have an onsite presence at Headquarters in San Rafael, CA. However open to virtually based employees.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

California

Afton Scientific LLC

Supervisor, Quality Control Analytical Chemistry Laboratory

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.**

**Supervisor, Quality Control Analytical Chemistry Laboratory**

**Department:** Quality Control

**Reports To:** Manager, QC Analytical Lab

**FLSA Status:**  Exempt

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

Afton Scientific is seeking an experienced and collaborative **Supervisor, Quality Control Analytical Chemistry Laboratory** to provide day-to-day leadership for our Analytical Chemistry Laboratory. This position is responsible for supervising laboratory operations, supporting and developing laboratory personnel, ensuring compliance with cGMP and regulatory requirements, and providing technical leadership in support of pharmaceutical manufacturing and quality operations.

This opportunity is ideal for an individual who combines strong analytical chemistry expertise with proven leadership, sound decision-making, and a commitment to quality and continuous improvement.

**Compensation**

**$90,000 - $110,000 annually, depending on experience and qualifications.**

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

**Primary Responsibilities**

· Supervise daily operations of the Quality Control Analytical Chemistry Laboratory while supporting production and quality objectives.

· Assist in managing, coaching, and developing laboratory staff in partnership with the QC Analytical Chemistry Laboratory Manager.

· Perform and oversee analytical testing of pharmaceutical finished products, APIs, and raw materials in accordance with applicable pharmacopeial and regulatory requirements.

· Ensure laboratory operations comply with FDA, ICH, USP, NF, EU, JP, cGMP, GDP, and GLP requirements.

· Design, execute, document, and support validation of laboratory methods, instrumentation, equipment, and analytical techniques.

· Assist in developing, qualifying, and implementing analytical test methods.

· Analyze, interpret, and document laboratory results in accordance with approved procedures.

· Review laboratory documentation and executed testing for accuracy, completeness, and regulatory compliance.

· Coordinate preventative maintenance, calibration, and verification activities for laboratory instrumentation.

· Investigate technical issues, identify root causes, and implement effective solutions.

· Write, review, edit, and approve controlled documents, including SOPs, validation protocols, specifications, reports, investigations, and quality system documentation.

· Participate in client, internal, and regulatory audits while representing the laboratory in a professional manner.

· Support procurement of laboratory equipment and supplies while maintaining effective relationships with clients, vendors, and internal stakeholders.

**Minimum Qualifications**

· Bachelor's degree in Chemistry or a related scientific discipline.

· Minimum of five to seven years of pharmaceutical analytical laboratory experience.

· Demonstrated expertise with analytical instrumentation, including HPLC, FTIR, GC, Karl Fischer Titration (KFT), UV-Vis, and comparable technologies.

· Working knowledge of cGMP, GDP, and GLP principles within a pharmaceutical environment.

· Strong written and verbal communication skills.

· Proficiency with Microsoft Office applications and the ability to learn additional laboratory software systems.

· Ability to work on-site full-time and perform the physical requirements of a laboratory environment.

**Preferred Knowledge and Experience**

· Previous supervisory or team leadership experience in a pharmaceutical quality control laboratory.

· Experience reviewing SOPs, deviations, excursions, investigations, and quality documentation.

· Experience with biologics testing techniques such as ELISA, SDS-PAGE, CE-SDS, or icIEF.

· Experience supporting regulatory inspections and client audits.

· Strong problem-solving, organizational, and decision-making skills.

· Demonstrated commitment to quality, continuous improvement, and employee development.

**Leadership Competencies**

· Leadership & Accountability

· Coaching & Employee Development

· Communication & Collaboration

· Planning & Prioritization

· Technical Expertise

· Quality & Regulatory Compliance

· Continuous Improvement

· Sound Judgment & Decision Making

Virginia

AbbVie

Quality Systems Manager

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Manager Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, cosmetics, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of responsibility may include supplier qualification and approval, supplier risk management, , supplier change management, , and Approved Supplier List (ASL) governance. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

Responsibilities

- Ensure proper integration and support of quality regulations: drug, biologics, cosmetic, device and/or combination products.
- Lead project teams in planning, preparation, review and approval of quality documentation.
- Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, cosmetic, device and/or combination products including compliance with Corporate policies, processes and procedures.
- Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
- Manage and oversee the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
- Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
- Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing medical devices and combination products.
- Interact with internal and external partners for development of best practices in our quality systems and procedures.
- Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
- Oversee the implementation and management of training and education programs for various aspects of quality assurance.

Qualifications

- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
- 8+ years’ experience in quality assurance, quality oversight or relevant experience.
- Leadership of technical professionals and in leading cross-functional teams.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
- Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
- Strong oral (with all levels of management) and written communication skills needed.
- Excellent interpersonal skills a plus.
- Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Tris Pharma

Sr. Director/Executive Director, R&D/Clinical QA

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

We have an opening in our Monmouth Junction facility for an experienced R&D/Clinical Quality leader to oversee our small QA/R&D department. Title commensurate with experience.

The Senior or Executive Director, Research and Development Quality Assurance (R&D QA) is responsible for providing strategic leadership and oversight of assigned R&D/QA and GxP Compliance programs in support of Research & Development (R&D), Clinical Development, Pharmacovigilance, Medical Affairs, and related regulated activities. The incumbent serves as a senior Quality leader responsible for ensuring compliance with applicable global regulations, industry standards and company policies throughout the product development lifecycle.

She/he partners with R&D, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance and external partners to establish and maintain a robust Quality Management System (QMS) to support patient safety, data integrity, product quality and regulatory compliance. The incumbent also drives inspection readiness, risk management, quality culture, continuous improvement and organizational excellence across global development programs.

ESSENTIAL FUNCTIONS

Strategic Leadership

- Develop and execute global R&D Quality Assurance and Compliance strategy aligned with corporate objectives.
- Provide quality oversight for research, nonclinical, clinical development, pharmacovigilance, and medical affairs activities.
- Serve as a strategic business partner to executive leadership and development teams.
- Lead quality governance programs and participate in executive quality review forums.

QMS Oversight

- Establish, maintain and continually improve R&D Quality Management System ensuring compliance with: FDA regulations, ICH Guidelines (E6, E8, E9, E17, Q9, Q10), EU Clinical Trial Regulation, EMA, MHRA, PMDA and Global GCP, GVP, GLP, and applicable GxP regulations.
- Oversee Quality management including: SOPs, Deviations, CAPA systems, Change control, Vendor quality management.

Clinical Quality Assurance

- Lead GCP Quality Assurance programs supporting global clinical development activities.
- Oversee quality oversight of: Clinical trials, Clinical operations, Site management, CRO activities.
- Investigator site/CRO audits/Vendor audits/Clinical process audits/System audits.

Research & Nonclinical Quality Oversight

- Provide quality oversight for research and nonclinical development activities.
- Support compliance with applicable GLP and research quality requirements.
- Oversee audits of: Nonclinical laboratories, Research organizations, Contract testing facilities and Development partners.
- Ensure appropriate quality and compliance controls are integrated into development programs.

Pharmacovigilance and Safety Quality

- Provide quality oversight of Pharmacovigilance and Drug Safety systems.
- Ensure compliance with global GVP requirements.
- Oversee: Safety-related audits, Vendor oversight, Safety governance processes, Inspection readiness activities.
- Partner with Safety leadership to ensure robust adverse event reporting processes and patient safety protection.

Vendor and Partner Quality Management

- Develop risk-based oversight programs for CROs, CMOs, laboratories, consultants and development partners.
- Lead qualification, audit and performance monitoring programs.
- Ensure quality agreements are established and maintained.
- Evaluate vendor compliance risks and implement appropriate mitigation strategies.

Risk Management and Data Integrity

- Ensure implementation of Quality Risk Management principles consistent with ICH Q9.
- Drive proactive risk assessments across development programs.
- Establish and maintain robust data integrity programs consistent with ALCOA++ principles.
- Monitor emerging compliance risks and implement appropriate action plans.

Leadership and Talent Development

- Build, lead and develop a high-performing R&D and Clinical Quality organization.
- Promote a culture of accountability, collaboration, transparency and continuous improvement.

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

- SR DIRECTOR: Bachelors degree in science or related field and minimum 12 years quality and/or compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 8 of those years in roles with Quality Assurance leadership and/or management responsibility within R&D or Clinical Development). REQUIRED

- EXECUTIVE DIRECTOR: Bachelors degree in science or related field and minimum 15 years quality and/or compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 10 of those years in roles with Quality Assurance leadership and/or management responsibility within R&D or Clinical Development). REQUIRED

For SR or EX Director:

- Significant experience supporting global development programs and regulatory inspections REQUIRED
- Demonstrated experience managing Clinical Quality Assurance (CQA) and GxP compliance programs REQUIRED
- Proven experience leading global audit and inspection readiness programs REQUIRED
- Experience interacting directly with FDA, EMA, MHRA, PMDA and other regulatory agencies REQUIRED
- Experience managing and developing high-performing Quality organizations REQUIRED
- Demonstrated expertise REQUIRED in:
- Good Clinical Practice (GCP)
- Good Pharmacovigilance Practice (GVP)
- Good Laboratory Practice (GLP)
- ICH E6 (R3), E8, E9, E17
- ICH Q9 and Q10
- FDA regulations
- EU Clinical Trial Regulations
- Data Integrity and ALCOA+ principles
- Risk-based quality management
- Clinical trial systems and technologies

Work arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office.

Anticipated salary range:

SR Director - $ 235 to $ 255 k/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Ex Director- $ 250 to $ 275 k/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid

New Jersey

Novo Nordisk

Quality Control Chemist I - Virginia

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

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**

Conduct analytical testing on materials and products in accordance with cGMP, site & corporate procedures & policies.

**Relationships**

**Essential Functions**

- Analyse raw materials, intermediate and final API drug substance, pharmaceutical compounds and samples, which may include compiling & analysing data
- Ensure cleanliness of lab and restock supplies as needed
- Conduct review of peer data
- Maintain and adhere to cGMP guidelines
- Support communicating status and timing of analytical testing to internal clients
- Provide support in investigations of laboratory samples and help determine appropriate corrective and preventive actions
- Provide support to Deviations
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May require corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear respiratory protection, which includes medical surveillance and verification of pulmonary fitness. May be required to fully gown for entrance into GMP areas.

**Qualifications**

- Bachelor’s degree in Chemistry, Microbiology or science-related field from an accredited university required and a minimum of one (1) year of experience with laboratory procedures and analytical chemistry techniques required
- May consider an Associate’s degree in Chemistry, Microbiology or science-related field from an accredited college or university with a minimum of three (3) years of experience with laboratory procedures and analytical chemistry techniques required
- May consider a High School Diploma or GED with a minimum of five (5) years of experience with laboratory procedures and analytical chemistry techniques required
- Experience with GMP regulations and quality control procedures required
- Ability to troubleshoot laboratory equipment a plus
- Comprehensive knowledge of chemistry or microbiology and laboratory techniques required
- Good judgement and an understanding of chemistry theories and concepts required
- High consciousness for personal and laboratory safety required
- Detail-oriented with good documentation and record-keeping abilities required
- Good communication skills to effectively report findings and collaborate with other departments required
- Good collaboration skills with and interaction with many departments 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.

Maintenance Technician I

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

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**

Improve systems & equipment reliability on assigned process, reduce system/equipment downtime on assigned process & support operation of assigned process.

**Relationships**

Reports to Senior Project Manager – OFP.

**Essential Functions**

- Follow all safety & environmental requirements in the performance of duties
- Follow Standard Operating Procedures in performance of assigned duties
- Support the development & establishment of maintenance procedures, maintenance plans & spare parts lists for processes assigned
- Perform corrective & preventative maintenance on assigned process in a timely manner
- Ability to interpret mechanical & electrical specifications, drawings & other technical data sheets
- Ability to work rotating shifts, night shifts, extended shifts and/or weekends
- Ensure all maintenance activities are correctly documented in SAP
- Partner with process owners to actively improve performance & reliability of process equipment
- Contribute to growth & development of the maintenance team by training fellow technicians in areas of expertise, as well as learning new systems
- Use Systematic Problem Solving (SPS) tools to establish Root Cause Analysis & resolve equipment issues
- Suggest practical changes or improvements to equipment & department work practices
- Collaborate with Responsible Engineers & Manufacturing personnel to troubleshoot equipment problems
- Other accountabilities, as assigned.

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver’s license.

**Minimum Qualifications**

- Associate's Degree in relevant field or equivalent military/industry training, which includes a thorough understanding of mechanical, electrical & control systems required
- Minimum of one (1) year of relevant work experience required

**Preferred Qualifications**

- Regulated industry & solid dose manufacturing experience preferred
- Ability to read, write & understand technical documentation, SOP’s, Maintenance Plans, PM’s, work orders preferred
- Understanding of schematics, wiring diagrams, P&IDs & other technical documentation preferred
- Computer literacy preferred
- Experience with automated record systems such as SAP preferred
- Experience in planning/organizing work, managing execution, checking results & revising the work plan in accordance with the daily work plan a plus

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

Process Maintenance Technician I

**About the Department**

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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**

Identify potential issues and support improvement of reliability of systems and equipment and minimize system and equipment downtime for the designated process. Assist in the operation of the assigned process supporting low to moderate complexity issues.

**Relationships**

Reports to Manager.

**Essential Functions**

- Actively improve performance & reliability of process equipment
- Restore function to equipment in an effective & technically correct manner
- Actively participate in & support Event Response
- Perform corrective & preventative maintenance on assigned process
- Operate, monitor, control equipment, systems & processes assigned
- Support & implement system/equipment reliability improvement projects
- Support & assist in all aspects of process operations
- Record & review production data in Batch Production Records (BPRs) & associated forms
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver’s license.

**Qualifications**

- Associate’s Degree in Industrial Maintenance or relevant field required
- In lieu of Associate’s Degree may consider a High School diploma (or GED) with minimum of two (2) years of equipment maintenance experience required, preferably in a pharmaceutical manufacturing or related industry
- Knowledgeable in the following systems: Compressed Air, Electro-Mechanical controls, Electrical, Mechanical, Instrumentation and/or robotics preferred
- Ability & experience with automated records systems such as SAP, schematics, wiring diagrams & other technical documents preferred
- Computer literacy preferred
- Support planning & execution of process functions & assist in coordination of planned & corrective maintenance activities to ensure successful process performance a plus

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.

IDEAYA Biosciences

Director, Good Manufacturing Processes, Quality Assurance

**Non-Solicitation Policy and Notice to Agencies and Recruiters:**

**IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships**. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA.

Position Summary:

We are seeking a Director of Good Manufacturing Processes, Quality Assurance to join our IDEAYA Quality team. The Director, GMP, Quality Assurance will lead GMP QA oversight for drug products and biologics programs from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across CMC, manufacturing development, and IT Systems, while provided strategic Quality leadership across internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Reporting to: Senior Director, GMP & GDP

Job Description

**What you’ll do:**

· Collaborate to provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards.

· Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies.

· Collaborate cross-functionally with Information Technology staff to support computer system validation activities.

· Oversee QA support for development-stage manufacturing, analytical, and including review and approval of deviations, CAPAs, change controls, and protocol/reports.

· Collaborate cross-functionally with CMC staff, Regulatory Affairs, Clinical Operations, and Program Management to drive proactive Quality input into development programs.

· Provide Quality oversight of contract development and manufacturing organizations (CDMOs), and other GxP service providers (vendors) used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers.

· Lead or support Quality Agreements, risk assessments, audits, and service provider (vendor) qualification activities to ensure phase-appropriate compliance.

· Actively represent QA in technical development activities, including process development, method validation/transfer, batch record reviews, formulation work, clinical supply chain (including IMP release and product quality resolution), and computer systems validation.

· Collaborate on phase-appropriate quality system improvements for development-stage programs.

· Participate in Quality governance forums, providing expert input on GMP requirements and ensuring alignment with global Quality strategy.

· Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation.

· Create, maintain, and enhance Standard Operating Procedures Governing Development QA activities.

· Support investigations and root cause analysis of product or process issues related to clinical manufacturing.

· Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development programs.

· Responsible for final product Quality release/rejection and related processes.

· Support service provider and internal audits as necessary.

· Support oversight of Third-Party Logistics compliance.

· Create and maintain Standard Operating Procedures related to areas of responsibility including product release, design control, change management, technology transfer, etc.

· Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.

· Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.

· Additional responsibilities and duties assigned.

· All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

· Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

**Requirements:**

· BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.

· Minimum of 12 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 8 years supporting development-stage programs; advanced degree may substitute for years of experience.

· Minimum 5 years of direct GxP experience (GMP, GCP, GPV, and/or GLP) in a regulated environment supporting small molecule drug products and biologics.

· Minimum 3 years of direct GxP experience supporting computer systems validation.

· Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Part 210/211, 600s, ICH, EU Annexes, GAMP5, ISO 9001, ISO 27001), and compliance expectations across clinical development.

· Demonstrated success in QA oversight of CDMOs, CROs, and testing labs, including audit and service provider management experience.

· Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

· Direct experience with clinical manufacturing, analytical method development / validation, tech transfer, and pharmaceutical development.

· Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs.

**Travel required \[Yes / No\]:** Yes

**Percentage of time in a year:** up to 10% per year

**Domestic/International:** Domestic and International

**Physical Demands and Work Environment**

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

- The employee is required to be on-site in our company offices for a minimum of four days per week.
- The employee will be required to stand and/or walk for up to 3 hours a day and sit for up to 8 hours a day; use hands to handle or feel objects including keyboard and telephones.
- The employee may occasionally lift and/or move up to 15 pounds.
- The noise level in the work environment will vary by location but is usually moderate.

**Lab-based Employees**

· The employee is required to be onsite 5 days per week

· The employee will be required to use their hands to manipulate objects including research chemicals, labware, equipment interfaces, and keyboards both inside and outside of fumehoods, and the employee will be required to carry lab material weighing up to 10 pounds (e.g. racks of solvent-filled test tubes) between fumehoods or between laboratory rooms

· The employee will be required to work while wearing appropriate PPE, including lab coat, protective gloves, and safety glasses

**Total Rewards**

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Director, Good Manufacturing Processes, Quality Assurance is $200,000 - $247,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

Manager, eQMS Technologies

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Manager, eQMS Technologies supports data-driven quality and compliance decisions by advancing analytics, AI-enabled insights, measurement solutions, and electronic quality management system capabilities across RDQA, R&D, and Enterprise Quality. This role partners with Quality, Business Technology Services, and process owners to translate business needs into requirements, improve data quality and accessibility, and deliver dashboards, metrics, and advanced analytics that support continuous improvement, global regulatory compliance, informed decision-making, and proactive risk management.

- Support the development and execution of quality analytics and AI roadmaps aligned with RDQA, R&D, and Enterprise Quality priorities.
- Build and maintain automated reporting, dashboards, KPI frameworks, and eQMS health metrics to monitor quality process performance and compliance.
- Develop advanced analytics and AI capabilities, including trend, anomaly, and predictive risk signals, to identify quality and compliance risks earlier.
- Partner with process owners and BTS to translate business needs into requirements, data products, and insight-driven actions.
- Establish data definitions, quality controls, and governance for key quality datasets and metrics.
- Enable self-service use of dashboards and insights through training, playbooks, and documentation.
- Review and approve SLC documentation to support compliant use of data and models in regulated environments.
- Support eQMS system ownership responsibilities, including system health monitoring, release/change coordination, issue escalation, user access/process support, and partnership with BTS and process owners to ensure systems remain fit-for-purpose, compliant, and aligned with business needs.

Qualifications

Required:

- Bachelor’s Degree in Pharmacy, Engineering, Computer Science, Data/Analytics, Business, or relevant course of study
- 4–6 years of experience in quality systems, engineering, data/analytics, or business support in a regulated environment
- Demonstrated experience developing metrics, dashboards, and analytical insights for process performance and compliance monitoring
- Working knowledge of data fundamentals (data modeling, data quality, governance) and analytical methods (descriptive/inferential statistics, trend analysis)

Preferred:

- Experience with BI and analytics tooling (e.g., Power BI or similar) and query languages (SQL); scripting/analysis in Python, R or similar is a plus
- Experience applying machine learning/AI techniques to operational quality problems (e.g., risk prediction, signal detection, text analytics) and understanding of model lifecycle considerations (monitoring, bias, drift)
- Experience implementing or enhancing computerized QA/eQMS solutions with a focus on data enablement and insights
- Knowledge of tools and techniques that can be leveraged into actionable activities and influence decision making
- Knowledge of Risk Management principles to help organization focus on the most impactful activities
- Quality Systems knowledge and related experience
- Travel: Yes, 10 % of the Time

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Quality Control Environmental Monitoring Scientist II

**About the Department**

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

**The Position**

This position is the subject matter expert on industrial/pharmaceutical Environmental Monitoring for the facility. Ensures facility program is in line with industry, regulatory and corporate practice. The individual exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions, while maintaining a high level of compliance with cGMP. Highly independent and self-motivated, receives no instruction on routine work/prioritization and general instructions on new assignments. Skilled in matrix leadership, inspires others.

**Relationships**

Reports to: According to the organizational chart.

Number of subordinates with direct/indirect referral: n/a.

**Essential Functions**

- Site lead for the Environmental Monitoring (EM) program at site NNUSBPI. This includes area monitoring and aseptic contamination control programs and Quality risk assessment management
- Technical subject matter expert on microbiological assays, techniques and industry practices
- Participates in site audits and inspections from outside authorities; responsible for area monitoring
- High degree of understanding with respect to GMP and compliance; able to assimilate complex issues and distill recommendations into concrete actionable plans
- Collaborates cross functionally to provide EM support, this includes EM-program establishment/new construction support, investigation support, coordination of study support, EM based risk assessments and data review/analysis
- Leads training and education on basic microbiology and aseptic behaviour as needed
- Responsible for protocol and report generation to support area monitoring facility qualification
- Organizes and reviews EM trending data and writes reports summarizing the trends, independently
- Handles major deviations, CAPA investigations and corrective actions. Owns SPS and facilitates A3
- Investigates and resolves issues related assay failures, system deficiencies, deviations and equipment / assay troubleshooting, with no assistance
- Reviews/updates test method and program SOPs as needed
- Creates methods and procedures on new assignments as required
- Clean utility monitoring and risk assessment
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
- Other duties as assigned

**Physical Requirements**

0-10% overnight travel required. The ability to climb, balance, stoop, kneel, crouch, crawl, reach, stand and walk. The ability to push, pull, lift, finger, feel and grasp. The ability to speak, listen and understand verbal and written communication. Repetition including substantial movement of wrists, hands and or fingers. Lifting up to 33lbs/15kg of force occasionally and/or up to 30 pounds of force frequently and/or up to 10 pounds of force constantly to move objects. The worker is required to function in narrow aisles or passageways. Visual acuity to perform close activities such as: reading, writing and analysing; and to determine the accuracy, neatness and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: inside and outside conditions including temperature changes; proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals, fumes, odours, dust, mists, gases, or poor ventilation.

**Qualifications**

- Education and Certifications:
  - Bachelor’s degree in microbiology, biological sciences or related field required
  - Master’s degree in microbiology, biological sciences or related field preferred
  - PhD in degree in microbiology, biological sciences or related field preferred
- Work Experience:
  - Bachelor’s degree with a minimum of eight (8) years in the pharmaceutical/biotech industry required
  - Master’s degree with a minimum of six (6) years in the pharmaceutical/biotech industry preferred
  - PhD degree with a minimum of two (2) years in the pharmaceutical/biotech industry preferred
  - Three (3) years of experience in project management activities and cross functional team coordination preferred
  - Desirable to have a minimum two (2) years of experience in a lead role within a biotech/pharmaceutical environmental monitoring program preferred
- Knowledge, Skills and Abilities:
  - Demonstrated ability to manage development associate staff is required
  - Prior experience authoring IND or BLA sections is desirable
  - Excellent written and oral communication and presentation skills. Excellent organizational skills

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.

New Hampshire

Eagle Analytical

Quality Control Chemist

**Job Details**

**Description**

Position Summary

The Quality Control Chemist is responsible for the review, approval, and maintenance of analytical chemistry documentation and quality records to ensure compliance with regulatory and accreditation requirements. This role supports Eagle Analytical’s Quality Management System by reviewing analytical methods, validation documentation, laboratory data, reports, and quality investigations while ensuring adherence to cGMP, cGLP, ISO 17025, A2LA, and USP standards. The position works closely with laboratory operations to maintain data integrity, regulatory compliance, and continuous improvement across chemistry testing functions.

What You Will Do

- Ensure compliance with Eagle Analytical policies, Standard Operating Procedures (SOPs), and the Quality Management System.
- Interpret and apply regulatory and accreditation standards, including ISO 17025, cGMP, cGLP, USP, and A2LA requirements.
- Support regulatory inspections, client audits, and accreditation assessments as required.
- Write, review, and approve SOPs, work instructions, forms, and quality records to ensure regulatory compliance and operational consistency.
- Review and approve analytical test methods and related documentation for chemistry testing, including UV-Vis spectrophotometry, HPLC, HPLC-MS/MS, GC-MS, and other analytical instrumentation.
- Review laboratory test reports, chemistry logs, worksheets, validation protocols, and validation reports.
- Ensure analytical data integrity, accuracy, completeness, and traceability.
- Review and approve quality investigations, including Out-of-Specification (OOS), Nonconformance Reports (NCR), Deviations (DV), Corrective and Preventive Actions (CAPA), change controls, and customer complaints.
- Evaluate root cause analyses and corrective action plans for process and laboratory-related issues.
- Create audit finding reports and determine appropriate corrective and preventive actions.
- Support and conduct internal audits of quality systems and documentation.
- Perform routine walk-through audits to ensure ongoing compliance across laboratory departments.
- Manage auditing, storage, and retention of quality documentation and quarantined materials.
- Prepare and maintain quality-related training materials as assigned.
- Support continuous improvement initiatives related to quality systems, documentation, and laboratory compliance.
- Assist in creating and maintaining quality manuals, procedures, and other controlled quality documents.
- Perform additional duties and special projects as assigned to support quality and regulatory objectives.

Who You Are

- Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline required.
- Experience in a regulated laboratory environment (ISO 17025, cGMP, cGLP) preferred.
- Experience supporting analytical chemistry testing laboratories is strongly preferred.
- Strong understanding of analytical chemistry techniques and instrumentation, including HPLC, HPLC-MS/MS, GC-MS, and UV-Vis.
- Working knowledge of method validation, data review, and laboratory quality systems.
- Experience reviewing GMP/GLP documentation and quality investigations.
- Strong attention to detail and commitment to data integrity and compliance.
- Excellent written and verbal communication skills.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Proficiency with Microsoft Office applications and electronic document management systems.
- ASQ preferred

Who We Are

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.

**Qualifications**

**Skills**

**Behaviors**

**Preferred**

Team Player: Works well as a member of a group

Dedicated: Devoted to a task or purpose with loyalty or integrity

Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

:

**Motivations**

**Preferred**

Goal Completion: Inspired to perform well by the completion of tasks

Self-Starter: Inspired to perform without outside help

:

**Education**

**Required**

Bachelors or better in Chemistry or related field.

**Preferred**

Bachelors or better in Biochemistry or related field.

**Experience**

**Licenses & Certifications**

**Preferred**

Certification in HPLC

Equal Opportunity Employer

Texas

Quality Control Microbiologist

**Job Details**

**Description**

Position Summary

The Quality Control Microbiologist performs quality review activities supporting both sterile and non-sterile microbiological testing. This role is responsible for reviewing routine microbiology data, documentation, and quality investigations to ensure compliance with cGMP, cGLP, ISO 17025, A2LA, and USP requirements, as well as Eagle Analytical’s Quality Management System. The position works closely with laboratory operations to maintain data integrity, regulatory compliance, and continuous improvement across microbiology testing functions.

What You Will Do

- Ensure compliance with Eagle Analytical policies, Standard Operating Procedures (SOPs), and the Quality Management System.
- Interpret and apply regulatory and accreditation standards, including ISO 17025, cGMP, cGLP, USP, and A2LA requirements.
- Support regulatory inspections, client audits, and accreditation assessments as required.
- Review microbiological test data and documentation related to sterility, endotoxin, bioburden, microbial limits, environmental monitoring, and particulate matter testing.
- Verify data integrity, accuracy, completeness, and traceability for laboratory worksheets, logbooks, and reports.
- Maintain accurate and compliant quality records and documentation.
- Review and approve quality investigations, including Out-of-Specification (OOS), Nonconformance Reports (NCR), Deviations (DV), Corrective and Preventive Actions (CAPA), change controls, and customer complaints.
- Evaluate root cause analyses and corrective action plans for laboratory and process-related issues.
- Prepare audit finding reports and determine appropriate corrective and preventive actions.
- Support and conduct internal audits of quality systems and microbiology laboratories.
- Perform routine compliance walk-through audits to ensure ongoing adherence to regulatory and quality requirements.
- Manage auditing, storage, retention, and control of quality documentation and quarantined materials.
- Write, review, and approve SOPs, work instructions, forms, and quality records to ensure regulatory compliance and operational consistency.
- Assist in creating and maintaining quality manuals, procedures, and controlled documentation.
- Prepare and maintain quality-related training materials as assigned.
- Communicate findings, trends, and risks with laboratory management and quality leadership.
- Support continuous improvement initiatives related to quality systems, documentation, and laboratory compliance.
- Perform additional duties and special projects as assigned to support quality and regulatory objectives.

Who You Are

- Bachelor’s degree in Microbiology, Biology, or a related life science required.
- Experience in sterile and/or non-sterile microbiology testing preferred.
- Knowledge of cleanroom practices and microbiological testing principles.
- Experience working in a regulated laboratory environment (ISO 17025, cGMP, cGLP) preferred.
- Experience reviewing GMP/GLP documentation and quality investigations preferred.
- Strong attention to detail with a demonstrated commitment to data integrity and regulatory compliance.
- Excellent written and verbal communication skills.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Proficiency in Microsoft Office applications and electronic document management systems.
- ASQ certification or related quality credentials preferred.

Who We Are

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.

**Qualifications**

**Skills**

**Behaviors**

**Preferred**

Team Player: Works well as a member of a group

Dedicated: Devoted to a task or purpose with loyalty or integrity

Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

:

**Motivations**

**Preferred**

Goal Completion: Inspired to perform well by the completion of tasks

Self-Starter: Inspired to perform without outside help

:

**Education**

**Preferred**

Bachelors or better in Biochemistry or related field.

Bachelors or better in Biology or related field.

Bachelors or better in Microbiology or related field.

Bachelors or better in Microbiology and Molecular Cell Sciences or related field.

**Experience**

**Licenses & Certifications**

Equal Opportunity Employer

Senior Auditor, Compliance Internal Audit

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board.

Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture.

The scope of compliance audits may include, but is not limited to, the following areas:

• Anti-Bribery / Anti-Corruption

• Promotional / Non-promotional practices

• Third Party Relationships

• Grants & Donations/Research Funding

• Monitoring & Transparency Reporting

• Patient Support Programs

• Contracting / Pricing

• Privacy Laws

Responsibilities

- Internal Audit Key Pillar: Execution
  Our leading pillar is focused on executing our audits and services in accordance with Institute of Internal Audit (IIA) standards, AbbVie Code of Conduct, and other internal policies. We drive meaningful dialogue, analysis, and tools that allow us to partner with our stakeholders on key decisions, aimed at assessing and improving AbbVie’s control environment.
- Internal Audit Key Pillar: Engagement
  We take pride in how we engage with stakeholders and each other – respectfully, ethically, and with AbbVie’s success and our patients at the forefront of our work. We rely on and challenge each other, as peers, knowing that at the core of every successful team is trust, partnership, and respect
- Internal Audit Key Pillar: Development
  The core success of our team is reliant on our talent. We focus on developing members of the audit team to execute audits/services, provide opportunities for training, and upskill other focus areas of each individual. We also continuously assess our culture to allow for an environment that cultivates and sustains an atmosphere of self and team development.
- Planning and executing audits of various processes/locations, both U.S. and international.
- Compile and analyze large sets of data from multiple sources (such as SAP, payroll and various compliance documentation databases).
- Partner with peers in creating a risk assessment analysis of a proposed audit of entities, processes or critical systems.
- Prepare and present audit findings to audit leadership and business stakeholders.
- Identify and communicate risk & control themes to various stakeholders.
- Assist with investigations as requested.
- Demonstrate a high degree of soft/presentation skills.

Qualifications

- At least 3 years of experience with a major public accounting, consulting or law firm in a client-facing capacity
- Bachelor’s Degree.
- Professional certifications/degrees a plus: CIA, CPA, CFE, MBA, JD
- Broad knowledge and experience in FCPA and/or the healthcare industry
- 15 – 35% travel to AbbVie's international and U.S. locations required
- In office/face-to-face interaction at company’s head office and audit locations

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Amgen

Program Manager

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.

**Program Manager**

**What you will do**

Lets do this! Lets change the world! The **Program Manager** partners closely with 3 Executive Directors **for Precision Medicine Diagnostic & Supplier Quality, Safety & Medical Quality and Quality Data Analytics and Process Management** to drive execution of strategic priorities. This role integrates strategic planning, operational excellence, organizational effectiveness, communications, portfolio coordination, and transformation to enable leadership focus on business priorities. In close partnership with the RDQ Strategy & Performance and Operations Director, this role helps translate enterprise and RDQ strategic priorities into coordinated operational execution across supported capabilities while ensuring consistent approaches, templates, governance, and business processes across the organization.

**Key responsibilities include:**

**Strategic Planning & Execution**

- Partner with capability leaders in Precision Medicine Diagnostic & Supplier Quality, Safey & Medical Quality and Quality Data Analytics and Process Management to develop and execute annual strategic priorities, operating plans and measurable deliverables
- Coordinate execution of RDQ priorities across supported capabilities through standardized templates, governance, and business processes to ensure consistent delivery
- Monitor organizational objectives, milestones and dependencies
- Identify operational risks and recommend mitigation strategies

**Business Operations**

- Partner with capability leaders in Precision Medicine Diagnostic & Supplier Quality, Safey & Medical Quality and Quality Data Analytics and Process Management to co-lead planning and execution of leadership team meetings and organizational forums (e.g. performance management reviews)
- Assist in development presentations for governance, dashboards, decision materials, and meeting content
- Drive follow-up of leadership decisions and action items
- Coordinate preparation of standardized business materials, executive updates, operating review content, and leadership communications using common RDQ templates and formats to promote consistency and efficiency
- Serve as the primary operational liaison between supported capability leadership and the Strategic Performance & Operations Director to coordinate information flow, deliverables, and business planning activities
- Support Strategic Performance and Operations Director with RDQ budget planning and management

**Functional Transformation and Program Management**

- Coordinate key functional initiatives related to Precision Medicine Diagnostic & Supplier Quality, Safey & Medical Quality and Quality Data Analytics and Process Management
- Partner with the Strategic Planning & Operations Director to operationalize enterprise initiatives within supported capabilities, ensuring strategic direction is translated into actionable implementation plans
- Monitor timelines, deliverables, and interdependencies
- Facilitate strategic workshops and planning sessions for key functional initiatives
- Support implementation of transformation (e.g. new operating models, organizational changes)
- Engage with Continuous Improvement for Organizational Change Management strategies and best practices
- May support special projects, as assigned by manager

**Operational Excellence**

- Improve organizational effectiveness for Precision Medicine Diagnostic & Supplier Quality, Safey & Medical Quality and Quality Data Analytics and Process Management by implementing standardized business processes, governance practices, templates, and tools that enable consistent execution across RDQ

- Build and/or manage organizational knowledge repositories (e.g. SharePoint, MS Teams)
- Support workforce planning and organizational capacity planning
- Monitor organizational health metrics and recommend improvement actions

**Leadership Support**

- Serves as a trusted partner to capability leadership by translating strategic direction into coordinated execution plans, tracking progress, and facilitating alignment across functions
- Collaborates closely with the Strategic Performance & Operations director and peer Program Managers to ensure enterprise priorities, governance activities, and leadership requests are executed consistently across RDQ
- Thinks strategically while executing operationally
- Applies continuous improvement mindset and problem-solving skills in proactively identifying opportunities to improve operational excellence
- Ability to navigate ambiguity and changing priorities with agility in a fast-based, dynamic environment
- Influences without authority

**What we expect of you**

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

**Basic Qualifications:**

- Doctorate degree OR
- Master's degree and 2 years of relevant experience (program management, business operations, quality assurance, R&D) OR
- Bachelor's degree and 4 years of relevant experience (program management, business operations, quality assurance, R&D) OR
- Associate's degree and 8 years of relevant experience (program management, business operations, quality assurance, R&D) OR
- High school diploma/GED and 10 years relevant experience (program management, business operations, quality assurance, R&D)

**Preferred Qualifications:**

- Experience supporting leadership teams
- Strong skills in program or portfolio management in a matrixed organization
- Demonstrated ability to manage multiple priorities while maintaining attention to detail
- Experience developing strategic roadmaps and operating plans
- Familiarity with financial stewardship
- Proven track record with successfully integrating global teams with effective collaboration and emotional intelligence
- Proficiency with collaboration and AI tools (e.g. Microsoft PowerPoint, Excel, Teams, SharePoint, ChatGPT, Copilot)
- Excellent written and verbal communication skills
- Pharmaceutical, biotechnology, or healthcare industry experience, including knowledge of R&D quality and risk management, preferred
- Lean Six Sigma and PMP (Project Management Professional Certification

**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.

District of Columbia

Sanofi US

CQA Team Leader

**Job title**: CQA Team Leader

**Location**: Remote, US

**About the job**

The CQA Team Manager (CQA TM) has direct management and supervisory responsibility of a team of auditors and is primarily responsible for ensuring the training, coaching, motivation and development of the individuals in his / her team. The CQA TM leads and inspires them to maximize their capabilities, performance and overall utility. By doing this the TM ensures that clinical projects are properly supported through independent clinical audit assessments, inspection management, quality reviews and GCP advice in relation to audit and inspection activities, that audit activities are effectively conducted, and ensures continuous improvement of the quality standards to meet regulatory requirements.

This position reports to the Head of Clinical Quality Assessment and is an active member of the management team for the group.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main responsibilities:**

**Strategic Risk Based Audits**

- Oversees day-to-day performance of individuals ensuring appropriate coaching and training on ICH/GCP, relevant regulatory requirements and global, departmental and geographical QDs, policies and guidelines.
- Directly manages his/her team and business support staff, including objectives & performance management, individual development, administrative matters, and hiring as necessary. As part of the management team participates in the development of annual goals and objectives of the department.
- Directly leads and plays a key role in audit planning, actively participates in the development of the annual schedules and regular revisions of audit strategies.
- In collaboration with CQA Management team, contributes to the development, review and updates of the policies, procedures, guidelines and other standards, and ensures their implementation within his/her team
- Ensures appropriate implementation of planned audits and ensures his/her team resources are put to optimum use for all types of audits assigned, and ensures that skills are developed at team level.
- Responsible for the quality of the audits conducted by his/her team, including adequate conduct, reporting and follow-up of the audit activities as per departmental procedures, guidelines, etc. Ensures a quality driven risk-based approach to audit scope and reviews.
- Ensures the contribution of all members of his/her team to support key customers and provide GCP consultation in relation to audits and inspections, regulation interpretation and input / communication on functional or cross functional procedures. This includes support to internal and external clients for activities that support continuous improvement cycle such as Quality Reviews, participation in workgroups, etc.
- Participates in audits as needed with emphasis on complex objectives and/or as part of audit staff coaching, training, and assessment. During Investigator site audits, CQA Team Manager has direct access to subject individual data for records review and may have access to unblinded information/data. He/she is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.
- Utilize predictive analytics and real-time data insights to identify potential risks and opportunities associated with clinical trials. Asses and escalate those risks as needed.
- Leader in determining the needs and designing the associated strategy for assessing audit and inspection quality trends / alerts via Transversal Quality Reviews (service provider / process). Ensure assignment of appropriate resources for the development and delivery of Quality Reviews to functions and leadership teams.
- Under Head of CQA oversight, coordinates and supports the control and follow-up of outsourced / contracted GCP assessment activities.

**_Inspection Activities:_**

- Leader in coordination and support and/or directly participates in the inspection activities by regulatory / compliance monitoring authorities. Will hold leadership roles such as Inspector facing host, backroom manager, and QC lead.
- Lead and coach team members in:
  - the coordination and management of pre-inspection preparation visits,
  - providing support to the inspection conduct,
  - hosting site level inspections,
  - overseeing post regulatory inspection follow-up activities.

**_Process Optimization :_**

- Apply critical thinking to develop and implement data quality control measures, leveraging AI and machine learning for enhanced accuracy.
- Participate in streamlined digital workflows that reduce manual processes and enhance operational efficiency
- Participate in the development of quality documents, digital tools and processes to enhance efficiencies.

**_Basic Qualifications_**

- Bachelor's degree in Life Sciences, Medical Sciences, Natural Sciences, or a related scientific discipline, or equivalent experience.
- Minimum 10 years of relevant experience with a bachelor's degree, or 5 years of relevant experience with an advanced degree.
- Minimum 5 years of Clinical Quality Assessment experience and/or experience in Clinical Trials, including Monitoring or Clinical Trial Management, with a demonstrated track record of strong performance.
- Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain.
- Good working knowledge of standard computerized software.
- Good business communication skills in English (orally / in riting)
- General management experience with technical / scientific staff
- Demonstrated knowledge in digital transformation and agile methodologies.

**_Key Competencies_**

- Proficient in clinical trial management systems, data visualization tools, and digital collaboration platform.
- Ability to translate data into actionable insights and strategic recommendations. Be organized and autonomous in decision making.
- Ability to communicate clearly, and effectively, to foster a productive dialogue and to do so across multi-cultural environments and in complex and/or sensitive situations.
- Effective people management and leadership skills, including the ability to serve as a change agent.
- Ability to work as a team builder, listening, promoting exchanges, mentoring and coaching. Motivating a team to support decisions and directions in times of change.

**_Technical Skills_**

- Expertise in clinical trial management systems and eClinical platforms
- Proficiency in data visualization and analytics tools
- Understanding of digital health technologies and their application in clinical trials
- In depth working knowledge of current regulations, guidelines and good practices pertaining to clinical development.

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Be part of a pioneeringbiopharmacompany that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to sparknew ideasand drive breakthroughs.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Join our Clinical Quality Assessment team and contribute to ensuring the quality of our clinical trials, through a risk-based and digital approach, and help accelerate medical breakthroughs

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#LI-Remote

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Nationwide

Aspen Neuroscience

QA Associate II (2 Positions)

The Quality Assurance Associate II supports Quality Assurance operations by ensuring materials, processes, and products are manufactured and documented in compliance with current Good Manufacturing Practices (cGMP) and company procedures. This role applies professional quality principles to routine and moderately complex quality activities, exercises judgment within established guidelines, and collaborates cross-functionally to support product quality and compliance. Work is performed with minimal day-to-day supervision and general guidance on new or complex assignments. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

**DUTIES AND RESPONSIBILITIES:**

- Review manufacturing batch records, analytical test results, environmental monitoring data, utility data, deviation records, and other quality documentation required to support the disposition of raw materials and manufactured product lots.
- Assess and support the timely closure of deviations, discrepancies, CAPAs, laboratory investigations, change controls, and nonconformance records in accordance with established procedures.
- Perform independent review of GMP documentation and coordinate correction of documentation errors or omissions, as needed.
- Conduct QA line clearance inspections, housekeeping assessments, and manufacturing process observations to verify compliance with approved procedures.
- Apply established quality standards and procedures to make routine quality decisions and escalate issues requiring additional review.
- Support the release of raw materials, equipment and supplier qualification activities.
- Participate in internal and external audit activities by providing documentation, information, and quality support.
- Contribute to quality investigations and change control activities by gathering information, performing assessments, and supporting implementation of corrective and preventive actions.
- Assist in maintaining quality systems and identifying opportunities for process improvements that enhance compliance and operational effectiveness.
- Provide process guidance and training to personnel on documentation and quality system requirements Identify potential compliance concerns and escalate issues to appropriate quality leadership for resolution.
- Draft, revise, and review standard operating procedures (SOPs), forms, and manufacturing documentation in accordance with established document control practices.
- Collaborate effectively with Manufacturing, QC, Facilities, Supply Chain, and other functional groups to support quality objectives

**EDUCATION AND EXPERIENCE:**

- Bachelor’s degree in biological sciences or relevant field with minimum 2 years of GMP manufacturing experience.
- Experience working in a regulated environment (GMP, GLP) is required. Experience applicable to cell therapies is a plus.
- Experience in aseptic technique, drug safety testing, and environmental monitoring is a plus.
- Experience in controlled (ISO 5/ISO7) clean room environments is a plus.

**JOB SPECIFICATIONS:**

- **Quality Systems Knowledge:** Working knowledge of cGMP regulations, quality principles, and company procedures to support compliant manufacturing and quality operations.
- **Documentation Review:** Strong proficiency in reviewing GMP documentation, identifying discrepancies, and ensuring accurate, complete, and compliant records.
- **Problem Solving:** Sound judgment in evaluating routine and moderately complex quality issues, applying established procedures, and escalating concerns when appropriate.
- **Attention to Detail:** Meticulous approach to record review, investigations, and quality documentation with a focus on accuracy and consistency.
- **Collaboration:** Demonstrated effectiveness in building productive relationships across varying department teams to resolve issues and achieve shared objectives.
- **Communication:** Effective verbal and written communication skills, including documentation, training support, and cross-functional interactions.
- **Adaptability:** Comfortable managing competing priorities and adjusting to changing business needs in a fast-paced environment.
- **Technical Proficiency:** Experience using Microsoft Office applications and electronic quality management systems within a regulated environment.
- **Cleanroom Operations:** Qualified or capable of becoming qualified to work in controlled cleanroom environments while maintaining gowning certification requirements.
- **Schedule Flexibility:** Willingness to support manufacturing operations through flexible scheduling, including occasional evenings and weekends during production campaigns.

**WORKING CONDITIONS**

Office and Lab environment. While performing the duties of this Job, the employee is

frequently exposed to toxic or caustic chemicals. This is an indoor position requiring the

ability to perform experiments in the laboratory, and type and use a computer. May work in Cleanroom for an extended period of time.

**PHYSICAL DEMANDS**

While performing the duties of this Job, the employee is Occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.

**EEO and Employment Eligibility:**

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

**Total Rewards and Culture:**

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

The anticipated salary range for candidates who will work in San Diego is $75,600 - $92,400 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.

Intellia Therapeutics

Vice President, Quality Management Systems and Digital Compliance

**Why Join Intellia?**

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

**How You Will Achieve More:**

The Vice President of Quality Management Systems is responsible for defining and executing the enterprise-wide quality vision that enables organizational growth from clinical development through commercial operations. As a transformational leader and executive sponsor for quality system modernization, this position drives digital transformation through eQMS implementation, establishes robust governance frameworks, and ensures sustained regulatory compliance and inspection readiness. The Vice President of Quality Systems and Digital Compliance will own the strategic vision for data integrity and governance programs including AI/ML quality applications and digital innovation. This role will develop and lead a high-performing quality team focusing on a culture of quality excellence and serve as a strategic partner to executive leadership across R&D, Manufacturing, Regulatory Affairs, and Commercial Operations. This executive role anticipates regulatory trends, manages enterprise risk, and positions quality as a competitive differentiator that directly contributes to business value and organizational success in bringing life-changing therapies to patients.

**Responsibilities:**

Enterprise QMS Strategy & Vision

- Define and execute enterprise-wide QMS strategy aligned with corporate objectives and growth plans
- Serve as executive sponsor for quality system transformation initiatives supporting commercialization readiness
- Lead long-term strategic planning for quality infrastructure investments, technology roadmaps, and organizational capability building
- Anticipate regulatory trends and proactively position the organization to meet evolving compliance requirements
- Champion quality excellence as a competitive differentiator and driver of business value

Organizational Leadership & Transformation

- Lead enterprise-wide quality transformation and change management initiatives, driving cultural change and operational maturity
- Establish governance structures, decision-making frameworks, and accountability models across the quality system
- Build organizational consensus on quality priorities and resource allocation
- Represent Quality in executive forums, strategic planning sessions, and board presentations

QMS Architecture & Implementation

- Design, implement, and scale comprehensive quality systems from clinical through commercial stages, with focus on advanced therapy medicinal products (ATMPs)
- Establish QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company policies
- Own the Quality Management System strategic roadmap with multi-year planning horizons supporting pipeline expansion and future innovations

Quality Systems Management & Governance

- Provide executive oversight for critical quality processes including Deviations, CAPA, Change Control, Document Control, Complaints, Quality Risk Management, and Data Integrity programs
- Chair Quality Management Review processes, presenting system metrics, trends, and strategic recommendations to executive leadership
- Establish quality intelligence and analytics capabilities to drive data-informed decisions
- Drive continuous improvement initiatives and define KPIs that measure quality system performance and business impact

eQMS Implementation & Digital Compliance Leadership

- Lead enterprise digital transformation through adoption, validation, and optimization of electronic Quality Management Systems (eQMS)
- Oversee IT Quality, Computer System Validation (CSV), and Data Integrity programs ensuring compliance with 21 CFR Part 11, Annex 11, and GAMP 5
- Champion strategic vision for Data Governance & Integrity programs, including AI/ML quality applications and digital innovation
- Partner with IT leadership on GxP computer systems lifecycle compliance and drive investment decisions for quality technology stack

Inspection Readiness & Regulatory Compliance

- Ensure enterprise-wide readiness for global regulatory inspections and Pre-Approval Inspections (PAIs)
- Lead critical health authority inspections and third-party GMP audits
- Support regulatory submission strategies and authoring of product licenses and regulatory dossiers

Enterprise Risk Management & Operational Effectiveness

- Establish enterprise risk management framework integrating quality risk into corporate risk management processes
- Define enterprise quality metrics and drive operational effectiveness through data analytics
- Champion quality by design (QbD) and risk-based thinking
- Develop and oversee risk-based approaches for quality system governance
- Ensure proactive identification and mitigation of compliance risks
- Define common global effectiveness and efficiency metrics to drive end-to-end performance
- Implement key performance indicators (KPIs) to monitor QMS effectiveness and enable data-driven decision-making

Team Leadership & Talent Development

- Build, develop, and lead a high-performing organization of quality professionals
- Foster a culture of accountability, innovation, and continuous improvement
- Provide executive coaching and mentorship to quality leaders
- Champion diversity, equity, and inclusion initiatives and drive organizational effectiveness through structure optimization and talent acquisition

Cross-Functional Executive Partnerships

- Serve as strategic partner to R&D, Technical Operations, Supply Chain, Regulatory Affairs, and Commercial Operations leadership
- Collaborate with Legal, Finance, and Corporate Development on compliance risk management, due diligence, and integration activities
- Partner with Human Resources on quality training strategy, organizational design, and change management
- Build external relationships with industry associations, regulatory agencies, and peer organization

Supervisory Responsibilities

- Build, develop, and lead a high-performing organization of quality professionals
- Foster a culture of accountability, innovation, and continuous improvement
- Provide executive coaching and mentorship to quality leaders
- Champion diversity, equity, and inclusion initiatives and drive organizational effectiveness through structure optimization and talent acquisition
- Provides constructive and timely performance evaluations.

**About you:**

- Expert-level knowledge of global health authority regulations including FDA, EMA, PMDA, and ROW requirements for pharmaceuticals and ATMPs
- Deep expertise in ICH guidelines (Q8, Q9, Q10, Q11), 21 CFR Part 11, EU GMP Annex 11, and emerging regulatory frameworks
- Proven expertise leading digital transformation initiatives including eQMS implementation, validation, and optimization
- Strong knowledge of Computer System Validation, data integrity, and digital compliance requirements
- Understanding of quality requirements across multiple product types (biologics, ATMPs) preferred
- Advanced expertise in quality management methodologies including Lean Six Sigma (Black Belt preferred), FMEA, Root Cause Analysis
- Strong proficiency with data analytics, business intelligence tools, and quality metrics dashboards
- Understanding of emerging technologies including AI/ML applications in quality, digital twins, and predictive analytics
- Knowledge of industry risk management concepts and their application to quality management
- BS, MS, or PhD in a field of science, engineering, pharmacy, or medicine.
- 15-20+ years quality leadership in Cell & Gene Therapy, biotech, or pharmaceutical industry with 10+ years managing quality systems and compliance function
- Direct experience leading multiple successful regulatory approvals and commercial launches
- Expert knowledge of FDA, EMA, and global health authority regulations
- Proven track record leading regulatory inspections
- Extensive experience implementing enterprise-wide eQMS and digital transformation initiatives
- Demonstrated success scaling quality organizations from clinical through commercial phases
- Strategic business acumen to translate quality into competitive advantage
- Ability to lead organizational transformation and drive cultural change
- Executive presence with proven ability to influence across all organizational levels
- Experience managing quality teams through high-growth environments
- Deep knowledge of ICH guidelines, 21 CFR Part 11, EU GMP Annex 11
- Strong expertise in data integrity, Computer System Validation, and digital compliance
- Advanced quality methodologies (Lean Six Sigma, FMEA, Root Cause Analysis)
- Experience with emerging technologies (AI/ML in quality, predictive analytics)

\#LI-Remote

**_EEOC Statement:_**  *Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.*

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $319,064.00 - $389,968.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please [click here](<https://www.intelliatx.com/careers/join-us/>).

Massachusetts

Civica Rx

Maintenance Technician, Facilities and Utilities

Position Summary

The Maintenance Technician, Facilities & Utilities, is responsible for the inspection, operation, maintenance, and repair of critical utility systems and associated equipment supporting the mechanical, electrical, plumbing, HVAC, safety, and waste management systems that support the facility. Position requires knowledge of utility and facilities equipment such as air handlers, boilers, air compressors, chillers, cooling towers, pumps & drives, heat exchangers, air compressors, hot water package units, clean steam and water for injection systems. Troubleshooting expertise on those systems and equipment. Have the capability to assess and perform repairs to critical utility systems to prevent impact on operations. The ideal candidate will have a consistent track record of achieving results in a fast-paced, aseptic manufacturing environment and of maintaining a positive mindset that drives a positive team culture.

This position follows a 2-2-3, 12-hour evening schedule: 6:00 PM-6:30 AM - 2 days on, 2 days off, 3 days on, 2 days off, 2 days on, 3 days off.

Essential Duties and Responsibilities

• Operate and maintain high-pressure steam boilers, cooling towers, compressors, pumps, and other related equipment following standard operating procedures.

• Perform daily rounds through the site to ensure equipment is in operational condition, complying with company safety policies.

• Read and record pressures, fluid levels, and other operational conditions. Produce computer reports and printouts as needed from results.

• Respond to site infrastructure equipment alarms and perform repairs as needed.

• Capable of performing work in one or more of the following trades: mechanical, pipefitting, HVAC/refrigeration, electrical, or plumbing.

• Troubleshoot utilities and facilities equipment as necessary, working with equipment owners, engineers, and vendors as needed to reach problem resolutions.

• Work with outside contractors to perform equipment repairs or service as needed.

• Partner with engineering, calibration, and spare parts teams to ensure proper inventory of key spare parts.

• Partner with engineering in the development and/or revision, as required, of preventive maintenance (PM) instructions of utilities and facilities equipment and/or systems.

• Completes required paperwork and documentation, work orders, and GMP documents in a clear, accurate, and timely manner.

• Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).

• Collaborate with Manufacturing, Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.

• Demonstrated ability to ensure a safe and effective working environment.

• Comply with all company policies and procedures, including safety and maintaining good housekeeping.

• Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.

• Periodically on call to monitor and respond to manufacturing equipment repairs and issues.

• Performing other duties as assigned.

Basic Qualifications (Knowledge, skills, and abilities)

• High school diploma with at least 2 years of experience in executing maintenance to utilities/facilities equipment, or an associate’s degree in a technical field.

• Ability to complete all paperwork neatly, correctly, and in accordance with Company guidelines.

• Work with computerized systems.

• Strong communication and collaboration skills, committed to meeting high-quality standards.

• Knowledge in the operation and maintenance of utility equipment such as boilers, air compressors, HVAC units, etc.

• Overtime and schedule adjustments may be required.

Preferred Qualifications

• Knowledge of GMP, regulatory requirements, and industry best practices.

• Ability to work autonomously and within established guidelines, procedures, and practices.

• Experience in using Computerized Maintenance Management Systems (CMMS).

• Knowledge of Microsoft Office Suite applications.

Physical Demands and Work Environment

The physical demands described here are those an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation may be provided to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee must frequently use their hands or fingers to handle, feel, or control objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. Able to climb stairs and ladders, and lift up to 50 lbs.

The company is an equal opportunity employer, a drug-free workplace, and complies with applicable ADA regulations.

QA Supervisor - Operations - 1st shift (369)

**Job Overview**

The Quality Assurance Supervisor-Operations will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuing excellence in quality and compliance. The Petersburg site serves as Civica’s new fill-finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications.

The role is essential to ensure the Petersburg site’s manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines.

Responsibilities of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations from the onset of building and qualifying the facility, leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

Responsibilities also include, but are not limited to, shop floor oversight and the generation, review, and/or approval of policies, procedures, reports, batch records, and other records necessary to support the design, implementation, and maintenance of manufacturing processes that meet or exceed FDA requirements.

**Essential Duties and Responsibilities:**

· Working across functions, establish and maintain the site’s quality systems related to manufacturing operations to enable reliable supply of quality generic medications to patients.

· Promote a quality mindset and quality excellence approach to all activities.

· Promote a safety mindset and focus on safety for all operational activities.

· Responsible for operational compliance aspects of sterile fill-finish manufacturing of products, including but not limited to aseptic process simulations, terminal sterilization, batch record review, batch disposition, and shop-floor quality.

· Ensure that all aspects of the handling and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.

· Establish and maintain Standard Operating Procedures and training consistent with CGMPs for QA shop-floor support.

· Provide leadership, direction, and support to ensure shop floor associates and operators are qualified, achieve a high level of competence, are motivated, and carry out their duties in a safe manner.

· Maintain written procedures and associated records for personnel qualification and training and support the delivery of compliance training sessions.

· Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.

· Support, review and approve equipment qualifications and product and process transfers, including validation, from development and/or other manufacturing sites.

· Establish and maintain Standard Operating Procedures, and training to ensure raw materials, excipients, APIs and components are qualified, and their suppliers are approved in accordance with Civica and GMP requirements.

· Establish and maintain Standard Operating Procedures and training to ensure that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labeling and drug products are released in accordance with the registered specifications.

· Responsible for Quality shop-floor oversight including real-time batch record review, response to deviations and implementation of corrective actions.

· Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.

· Participate in quality risk analysis.

· Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

· Travel is limited but may occasionally be required.

**Basic Qualifications and Capabilities:**

· Bachelor’s degree in a scientific discipline with a minimum of 5+ years of Quality/CGMP experience in the pharmaceutical industry. Experience in sterile injectable manufacturing and packaging operations is required.

· Strong project management, organization, and execution skills with a proven track record of shop floor manufacturing.

· Quality assurance experience across the product development and commercialization lifecycle.

· Participation and leading activities to support regulatory agency inspections required.

· Excellent interpersonal and written communication skills and experience using various software/electronic applications required.

· Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.

· Ability to work autonomously and within established guidelines, procedures, and practices.

· Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.

· Continuously looking for opportunities to learn, build skills, and share knowledge with others.

· Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.

· Prior experience in a supervisory role highly desired.

**Physical Demands and Work Environment:**

The physical demands described here are representative of those required of an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use hands or fingers to handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable.

QA Ops Shop Floor Associate (386)

**Position Summary:**

The Quality Assurance Operations Shop Floor Associate is part of the Quality Assurance Operations team at Civica’s Petersburg, Virginia manufacturing facility. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. This role will function to ensure ongoing compliance with cGMP requirements on the manufacturing floor.

**Key Responsibilities:**

- Provide Quality Assurance oversight on the manufacturing floor during all operations regarding procedures, reports, batch records, aseptic technique, gowning, nonconformances, product sampling, and/or other records as necessary to support the manufacturing processes.
- On-the-floor review of batch records during execution to ensure compliance with approved procedures, as well as communicate and resolve discrepancies with manufacturing operators and/or supervisors.
- Familiarity with electronic management systems such as Veeva, Deacom, and Blue Mountain RAM.
- Facilitate Quality oversight on the shop floor through walkthroughs, Gemba, and process observations to ensure full adherence to cGMP practices.

- Identify and implement improvements to procedures and processes as part of broader continuous improvement initiatives.

**Essential Duties and Responsibilities:**

- Working across functions to ensure operational compliance in all aspects of product manufacturing.
- Enforcing adherence to all Civica standard operating procedures (SOPs) while on the manufacturing floor.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operations activities.
- Ensure that on-the-floor review of manufacturing records, batch quantities, and accountability calculations are performed and completed accurately.
- Provide immediate support in the identification and documentation of nonconformances, deviations, or discrepancies on the manufacturing floor.
- Provide support as required to all manufacturing and processing areas within the facility, depending on job assignment and schedule.

**Basic Qualifications and Capabilities:**

- Bachelor's degree or above in a scientific discipline.
- Minimum of 2+ years of experience within a pharmaceutical, biotech, cell therapy, or medical device cGMP-regulated manufacturing environment.
- Experience in sterile pharmaceutical isolator technology, combination products, or medical devices.
- Demonstrated experience delivering training on cGMP regulations, SOPs, and quality systems.
- Excellent written and verbal skills and ability to present technical data effectively based on target audience.
- Ability to work in a fast-paced team environment and lead peers through changing priorities.
- Detail-oriented and task-focused with the ability to meet deadlines and support work prioritization.

**Physical Demands and Work Environment:**

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities this position requires include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable.