Quality

Frederick National Laboratory for Cancer Research

Preventative Maintenance & Compliance Specialist (Asset)

**Preventative Maintenance & Compliance Specialist (Asset)**

Job ID: req4699

Employee Type: nonexempt full-time

Division: Facilities, Maintenance & Engineering

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Facilities Maintenance and Engineering (FME) Directorate is responsible for laboratory space, administrative space, infrastructure, campus landscape, planning and design, and construction management at Frederick National Laboratory for Cancer Research.

The Preventive Maintenance & Compliance Specialist is responsible for developing, implementing, and managing comprehensive asset identification and tracking programs to ensure the optimal utilization, reliability, and maintenance of all equipment supporting scientific operations, animal welfare, and facility infrastructure across both the Main Campus and the ATRF Campus. This position directly supports the scientific mission by maintaining an accurate and complete inventory of physical assets, coordinating preventive maintenance activities, and ensuring compliance with NCI-Frederick policies as well as all applicable local, state, and federal safety standards.

**KEY ROLES AND RESPONSIBILIES**

- Conduct field surveys of all mechanical spaces to verify that assets are properly identified, clearly labeled, and accurately enter into Maximo.
- In coordination with the PM Maintenance Coordinator, develop, implement, and oversee asset life cycle maintenance programs to minimize downtime and ensure operational continuity.
- Review, input, and update Safety Plans for all assets to ensure compliance with EHS and OSHA policies.
- Maintain and revise Energy Control Procedures (ECPs) for all applicable assets to ensure adherence to safety and regulatory requirements.
- Collaborate with shop supervisors to regularly review and update Job Plans for each preventive maintenance activity, ensuring accuracy and compliance.
- Conduct condition assessments and analyze repair data to make recommendations for utility system upgrades, improvements, or replacements.
- Conducts a comprehensive spare parts inventory by reconciling warehouse inventory with asset materials recorded in Maximo.

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of a high school diploma or equivalent. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of five (5) years of craft/trade-related experience in maintenance, facilities, or asset management is required.
- Ability to frequently lift and carry items weighing up to 25 lbs.
- Must be able to walk, stand for extended periods, climb stairs, bend, stoop, and work in confined spaces and various environmental conditions (dusty, noisy, or outdoor settings).
- Experience using Enterprise Asset Management (EAM) or Computerized Maintenance Management Systems (CMMS).
- Strong analytical, organizational, and communication skills.
- Demonstrated ability to work collaboratively across multidisciplinary teams and manage relationships effectively.
- This position is considered safety sensitive and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program.
- Ability to obtain and maintain a security clearance.

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- Certification in Asset Management (e.g., IAM, ISO 55000, or equivalent).
- Experience in biomedical research, laboratory operations, or regulated facilities environments.
- Knowledge of complex research equipment, facility systems, and asset tracking technologies.
- Experience with Continuous Improvement and a demonstrated commitment to process optimization, operational efficiency, and best practices in asset lifecycle management.

**JOB HAZARDS**

- This position is subject to working with or has the potential for exposure to animals(s) and/or animal material(s).
- This position is subject to working with or has the potential for exposure to infectious material,
  requiring medical clearance and immunizations.
- This position is subject to working in or have the potential to exposure to high noise levels for
  extended periods of time required medical clearance.

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

55,400.00 - 81,600.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Maryland

Syngene International Ltd

Quality Analyst Document Control

**Job Title:** QA Analyst I

**Department:** Quality Assurance

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

*At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.*

**Job Summary:** The QA Analyst I will be responsible for scanning, filing, archiving, organizing, and maintaining an inventory of documents as well as assisting employees in providing assistance for technical writing and formatting documents for consistency, accuracy, and process flow to owners and authors of documents. They are accountable for the execution of daily activities as related to documentation record management, archive, and retrieval of GMP controlled documents ensuring the site complies with relevant regulations. The role will contribute to organizational management on all electronic and paper-based systems that support daily activities of documentation management and proper design.

**Primary Responsibilities:**

- Ensure maintenance of documentation archival and record chain of custody and traceability for onsite and offsite documents for easy identification and retrieval
- Execute daily activities that support documentation compliance and traceability to all executed activities
- Using a systematic approach, scan the contents of various binders and folders into identifiable and properly formatted PDF documents
- Edit the PDF files to ensure that they are bookmarked and linked appropriately
- Perform routine verification to ensure latest documentation archived accordingly
- Achieve and maintain SME status on all functional area application systems and reporting tools for the Electronic Data Management System (EDMS)
- Collaborate with team members and site customers to ensure timely deliverables for documentation and training objectives
- Provide end user assistance/training for document control procedures
- SOP generation and review, providing subject matter expertise to other document authors on site
- Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals
- Frequently interacts with direct manager, peers, internal customers, and other cross functional peers across Emergent

**Education & Qualifications:**

- Bachelor’s Degree in Scientific or related fields
- A minimum of three (3) years of cGMP in QA documentation in Pharmaceutical industry
- Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
- The ability to coordinate multiple priorities in a fast-paced environment
- Excellent organizational, analytical and problem-solving skills
- Experience in maintaining CGMP compliance preferred
- Excellent communication skills with the ability to interact with all levels throughout the organization

**Additional requirements for this role:**  Type/keyboard, visual acuity, stand, walk, sit, squat/kneel, sense of hearing, and lift/carry 15 lbs. Use phone, fax, copier and computer. Organize/coordinate, analyse/interpret, problem solve, make decisions, plan, communicate and prepare written communications.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Sanofi US

Senior Quality Specialist General Medicine VIE Contract

**Senior Quality Specialist General Medicine - VIE Contract**

- Location: United States of America, Framingham
- Target start date: 01/01/2027

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

**About the job**

*As*  **_Senior Quality Specialist General Medicine VIE_**  *within our Quality System team, youll interact extensively with North American manufacturing/packaging sites, contract manufacturers, and with sites inside and outside the US which manufacture products that include all dosage forms for numerous global markets. You will work closely with the contractors, quality team, supply chain, Manufacturing Science and Technology (MSAT), regulatory, and other appropriate groups to ensure compliance and continuous improvement in quality functions to ensure compliance with Current Good Manufacturing Practices (cGMPs) and regulatory submissions.*

*Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.*

*Ready to get started?*

**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:**

- Ensures the Quality and Regulatory compliance of products subcontracted to external entities on behalf of Sanofi in accordance with cGMPs and Sanofi Quality directives.
- Ensures the efficiency of Quality System implemented between Sanofi and the sub-contractors ensuring relevant management for complaints, deviations, change controls, non-conformities, or any activity aiming to ensure the production, the control, and the release/disposition of products accordingly with Quality, regulatory, and procedural requirements.
- Strengthens the Quality and Regulatory strategy particularly during crisis management and verify the implementation of the relevant action plans.
- Support the External Manufacturing North America Audit program by working with and conducting contractor audits to assure compliance with Sanofi Quality Directives, (cGMPs, and regulatory filings. Leads or participates in the subcontractors audits and managers the CAPAs that follow.
- Supports and manage projects assigned such as new product launch, onboarding/offboarding or subcontractors and products.
- Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filing, or other risks to Sanofi products.
- Develops and negotiates the subcontractors Quality Agreements defining the responsibilities between both parties and provides quality advice to subcontractors.

**About you**

**Experience:**

- 1-3 years in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry.
- Experience in third party manufacturing Quality and Regulatory function and/or same plat experience.

**Soft and technical skills:**

- Excellent oral and written communication skills in cGMP documentation
- Interpersonal skills to interface with suppliers and customers to develop privileged communications and relationships.
- Excellent teamwork and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects.
- Effectively communicate at all levels of associates in the Sanofi organization (from operator to vice president) or supplier and customer at all levels
- The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries, especially those related to handling product complaints and the associated regulations.
- Thorough knowledge of GMP's and regulatory requirements.
- Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations.
- Project management skills.

**Education:**

- Bachelors degree in Science or related field.

**Languages:**

- Fluent English (written & verbal).

**Why choose us?**

- Be part of a pioneering biopharma company where patient insights shape drug development.
- Work at the forefront of AI-powered science that accelerates discovery and improves outcomes.
- Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale.
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
- Work with AI, robotics, and next-gen automation to redefine global manufacturing and supply.

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofis Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.

\#LI-EUR

null

Massachusetts

Deputy Director of DS Manufacturing Quality Systems

**Job Title**: Deputy Director of DS Manufacturing Quality Systems

**Location:** Pearl River, NY

**About the job**

As Deputy Director, Drug Substance (DS) Manufacturing Quality Systems at our Pearl River site, you'll lead and develop a broad Quality Systems organization spanning Principal Investigators, Technical Writers, and Quality Systems Support Associates responsible for the full lifecycle of manufacturing quality records: deviation investigations, CAPAs, effectiveness checks, periodic reviews, and QMS document updates. You'll keep investigations on track, products moving, and patients supplied, all while driving a culture of continuous improvement and operational excellence. You'll be a key voice in audits and regulatory inspections, a coach to your team, and a connector across functions. If you thrive in a fast-paced, regulated environment where your decisions carry real business and patient impact, this role is for you.

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

**About Sanofi**

We're an R&D-driven, AI-powered biopharma company committed to improving people's 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 people's lives.

**Main responsibilities**

- Lead and develop an agile Quality Systems team including Principal Investigators, Technical Writers, and Quality Systems Support Associates coordinating work assignments to meet fluctuating business needs while sustaining a strong learning and development culture
- Own on-time closure of Drug Substance Manufacturing deviation investigations, CAPAs, effectiveness checks, and periodic reviews of departmental quality documents to meet site performance metrics and product release timelines
- Identify and resolve roadblocks by coordinating with support groups to ensure the Manufacturing Quality System Matrix remains current and comprehensive
- Review deviations, CAPAs, and other quality records for completeness, and conduct management-level review of minor, major, and critical events ahead of Quality Assurance review
- Oversee timely and accurate document updates within the Quality Management System (QMS), ensuring documentation remains current, compliant, and audit-ready
- Coach and develop the Quality Systems team, providing continuous feedback and challenging growth opportunities while reinforcing Sanofi's culture, values, and cGMP compliance standards
- Lead cross-functional engagement with key stakeholders (Manufacturing, Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance) to build consensus and drive timely closure of quality records
- Partner closely with the Head of Quality Assurance Operations and Inspection Readiness to align quality systems execution with site-wide QA strategy, audit readiness, and regulatory compliance priorities
- Serve as the site representative during internal and external audits and regulatory inspections, confidently defending investigation write-ups and quality documentation on behalf of the team
- Champion a continuous improvement culture by identifying and driving new tools, process changes, and cost-reduction initiatives that reduce deviations and improve cycle time efficiency across the Quality System
- Communicate progress, updates, and escalations accurately and effectively in writing and verbally across multiple levels of the organization and to regulatory agencies
- Ensure all Quality System operations are conducted in full compliance with cGMPs
- Available to work extended and flexible hours, including weekends, as business needs require

**Decision-Making Matrix (DAI)**

The Deputy Director, DS Manufacturing Quality Systems plays a leadership role in decision-making processes across quality systems, manufacturing operations, and regulatory compliance. Responsibilities are defined as follows:

**Deviation, CAPA, and Quality Record Closure**

- **D (Decider)**

Decides on investigation scope, risk classification, and closure readiness for deviations, CAPAs, and effectiveness checks in partnership with QA.

Approves final quality records prior to Quality Assurance review.

**Quality Systems Team Development and Work Assignment**

- **D (Decider)**

Assigns work, prioritizes investigations and quality documentation tasks, and determines team development plans and coaching strategies.

**Cross-Functional Consensus Building and Escalation**

- **A (Accountable)**

Accountable for facilitating cross-functional alignment with Manufacturing, Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance to resolve roadblocks and drive closure.

Escalates unresolved issues to senior leadership and support groups as needed.

**Site Quality Strategy, Audit Readiness, and Inspection Defense**

- **A/I (Accountable/Informed)**

Partners with the Head of Quality Assurance Operations and Inspection Readiness to align quality systems execution with site-wide QA strategy.

Accountable for representing the site and defending quality records during audits and inspections.

Informed of broader site quality strategy and regulatory intelligence.

**Continuous Improvement Initiatives and Process Changes**

- **D/A (Decider/Accountable)**

Identifies, proposes, and decides on process improvements, new tools, and cost-reduction initiatives within the Quality Systems organization.

Accountable for driving implementation and measuring impact on deviation reduction and cycle time efficiency.

**QMS Document Updates and Periodic Reviews**

- **A (Accountable)**

Accountable for ensuring timely and compliant updates to departmental quality documents and periodic reviews within the QMS.

Delegates execution to team members but retains accountability for completeness and compliance.

**cGMP Compliance and Regulatory Communication**

- **A (Accountable)**

Accountable for ensuring all Quality Systems operations are conducted in compliance with cGMPs.

Communicates progress, updates, and escalations to regulatory agencies and senior leadership.

**About You**

**Basic Requirements:**

- Bachelor's degree in Life Sciences, engineering, Business or any related field.
- 7+ years of experience in a cGMP-regulated pharmaceutical or quality environment, with demonstrated experience leading cross-functional initiatives, projects, or quality systems.
- Strong track record making risk-based decisions independently and managing multiple high-priority, high-visibility deadlines in a dynamic setting
- Demonstrated ability to lead cross-functional consensus-building with stakeholders across Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance
- Excellent written and verbal communication skills, with the ability to engage and influence stakeholders across all levels of the organization and with regulatory agencies.

**Nice to Have:**

- Prior experience managing direct reports or technical teams in a regulated environment is preferred but not required. Equivalent experience leading quality systems, project teams, or independent contributors will be considered.

**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.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

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-SP

\#LI-SP

\#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>)

New York

Daiichi Sankyo

Associate Director, Companion Diagnostics Leader

Job Description

Job Title: Associate Director, Companion Diagnostics Leader

Job Requisition ID: 1994

Posting Start Date: 10/4/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The primary responsibilities of this position are to assist in the development and implementation of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo’s Early and Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics.

**Responsibilities**

- Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act as CDx representative to GPT for early-stage programs.
- Assists CDx GPT representative by collaborating cross-functionally to ensure successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions.
- Contributes to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships to develop, implement and gain regulatory approvals for CDx assays. May function as the main point of contact to the Dx partner for CDx project contracts. Supports CDx analytical and clinical validation studies in collaboration with Dx-partner
- Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection
- Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally
- For late-stage programs, executes the Diagnostic development strategy for a project under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscape

**Qualifications**

**Education**

- BS/BA required
- MS or PhD preferred

**Experience**

- Minimum 4 years relevant work experience with PhD; minimum 7 years relevant work experience with MS; or minimum 11 years relevant work experience with BS/BA required
- Demonstrated track record of success working on multidisciplinary pharmaceutical /diagnostic development teams.
- Understanding of the IVD Development Process, with indirect or direct experience with Companion Diagnostics Development
- Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR etc.
- An understanding of how diagnostic development can shape drug development and commercialization is a plus.

**Competencies**

- Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas.
- Strategic and analytical skills with a proven ability to define, prioritize and balance responsibilities in accordance with business and team needs.
- Experience maintaining strategic direction while ensuring successful execution of project details.
- Solid interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams and at managerial levels of the organization across various functions and locations

**Travel**

Domestic and international travel may be required: 15%

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$166,720.00 - USD$250,080.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

New Jersey

Manager, QA System Management

Job Description

Job Title: Manager, QA System Management

Job Requisition ID: 2112

Posting Start Date: 9/17/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible to ensure efficiency, accuracy and standardization in high commitment level for document management and data integrity. The incumbent is responsible for authoring, review and manage the development of internal procedures to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and to manages a Quality Assurance Agreement system which provides a realistic and accurate information to oversee and support vendor qualification program and the relationship with contract organizations. Collect, conduct and evaluate data for critical operations related with Annual Product Reviews. Manages the completion of stability studies program of drug products marketed in US and exported from US.

**Responsibilities**

- Quality Assurance Agreements: Manages a comprehensive system for the establishment of local and global Quality Assurance Agreements in order to assure that all external contractors involved in manufacturing and testing of drug products for commercial and investigational purposes, drug substances, intermediates and service providers provide GMP compliant activities ensuring the stable and quality supply as per local and international regulations and guidelines satisfying DS requirements and supporting the company’s vision.
- Ensure proactive planning and completion for QA Agreements establishment and review process in a timely manner as necessary. Change Control System: Manages an effective Change Control System able to capture and deal with changes proposed by manufacturers, customers, internal improvements and/or Health Authorities requirements. Responsible to communicate in timely-manner with several internal and external partners and functions in order to properly address all the proposed changes, ensuring the right QA assessment and looking for the best strategy to avoid any impact for commercial and investigational products availability in order to cover patient needs.
- CAPA Management: Ensure oversight for CAPA Management activities in order to define and follow the completion plan up. Responsible to communicate in timely-manner with several internal and external partners and functions in order to ensure the deadline of CAPA plan is followed on rigor as per defined in the internal procedures. Product Data Management: Responsible to collect and/or evaluate data information from critical manufacturing steps process and authoring Annual Product Review as per internal procedures and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario to ensure that products are following high quality standards to meet patient needs.
- Responsible to lead the activities related with stability studies program performance in accordance with internal procedures and regulatory requirements in connection with contract testing laboratories to ensure the compliance for products marketed and/or distributed locally. May author or review stability studies protocol or reports. Provide the support for management and update of technical registration documents Quality Metrics: Collecting and analyzing data related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance and reporting Quality Metrics in a periodical manner and communicate this to Senior Management handling Quality Meeting sessions, identifying potential quality issues and proposing suitable solutions fostering a preventive mindset across the team and to the organization based on the metrics collected.
- Development of Standards and Procedures (SOPs) and Training: Liaise with GMP areas to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. Responsible to adhere and implement key global/regional QA GMP Standards, Procedures and Instructions. Supporting SOP authoring and reviewing process among GMP functions. Responsible to provide enough training for the related GMP and non-GMP activities involved with QA System Management processes.
- Cross-Functional Team Participation: Collaborate with the functional representatives within DSI and globally within the DSG network to align processes and procedures as they pertain to how the organization executes work and ensure alignment with industry regulations and best practices. Partner with local and global functions to provide guidance and oversight of specific processes. As part of global support, ensure cross-functional alignment and overall applicability across regions to support process excellence and compliance.

**Qualifications**

**Education Qualifications**

Bachelor's Degree in scientific discipline required; or Master's Degree or other advanced degree preferred

**Experience Qualifications**

- 4 or more years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit or equivalent experience required
- Experience with various pharmaceutical dosage forms preferred
- Direct experience dealing with multinational drug regulators. preferred
- Previous management experience preferred
- Solid understanding of quality management and continuous process improvement principles including global cGMP requirements. preferred
  **Travel Requirements**
  Ability to travel up to 10% of the time including overnight travel

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$127,280.00 - USD$190,920.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Director, Regulatory Affairs, Companion Diagnostics

Job Description

Job Title: Director, Regulatory Affairs, Companion Diagnostics

Job Requisition ID: 2194

Posting Start Date: 9/14/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.

**Job Description**

**Responsibilities**

CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing

- At the time of implementation of a CDx study/IVDR performance evaluation study & integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)
- Serve as the Point of Contact (PoC) for gathering country/region specific CDx RA requirements from local RA team members (e.g. from Japan, China, Australia, Canada, Korea etc.)
- For recruitment in EU: It is critical that this person has, and continues to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely registration of both therapeutic and diagnostic products in the EU as well as UK and Switzerland.

CDx RA Strategy: Represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically:

- Use of CTA/CDx within clinical trials
- Device protocols and SAPs
- Device non-significant/significant risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEs
- Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.
- Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)
- ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samples

Project Team Participation: Provide device-specific regulatory insight/guidance during CDx Indication Team & Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation of contingency/backup plans for CDx submission. Health Authority Submission Preparation: Assist with preparation of pre-submission documents and CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissions

- In collaboration with CDx lead work with Dx partners to ensure robust development of assay, participate in HA interaction for drug-related CDx topics/questions, and attend device company HA meetings as appropriate
- In collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company positions related to CDx for Health Authority interactions (for both sponsor and partner side)

CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these changes

- Assessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products
- Contribute to shared learning forums, workshops and training on new guidances, regulations to enterprise
- Sharing case studies with enterprise

**Qualifications**

**Education Qualifications**

- Bachelor's Degree preferably in a scientific discipline required
- Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD preferred

**Experience Qualifications**

- 7+ years relevant pharmaceutical experience including experience within Regulatory Affairs required
- Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals required
- Extensive experience developing companion diagnostics and devices required
- Experience of drug development and drug regulatory procedures.
- Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process required

**Travel Requirements**

Ability to travel up to 10% of the time. Occasional travel to Health Authority meetings in US and Europe, potentially Japan.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$184,240.00 - USD$276,360.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Dyne Therapeutics

Associate Director, Quality Management Systems

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Associate Director, Quality Management Systems is a key member of the quality team responsible for designing, scaling, and advancing a global Quality Management System (QMS) that supports Dyne’s transition to commercial operations. This role is responsible for key elements of the QMS including document control, records management and training ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations. The Associate Director partners cross-functionally to embed quality as a strategic enabler of business performance, ensuring systems are fit-for-purpose, inspection-ready, scalable, and efficient as the organization grows. This is a hands-on role that requires both strategic vision and operational execution.

This role is based in Waltham, MA.

**Primary Responsibilities Include:**

*QMS Strategy, Compliance & Inspection Readiness*

- Leads the evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10, FDA CFRs, and international regulatory standards
- Ensures QMS processes are phase-appropriate, risk-based, and designed to scale with organizational growth
- Establishes and sustains a proactive compliance model that supports continuous inspection readiness
- Serves as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions
- Provides strategic and operational leadership for GxP documentation and training programs, ensuring effective use and governance of the eDMS and LMS in support of the quality management system

*Core QMS Program Ownership*

- Oversees the end-to-end lifecycle management of quality documents, including policies, SOPs, and related controlled records, ensuring consistency, accuracy, and compliance with applicable regulations that achieves inspection readiness
- Drives and manage high-volume document authoring, revision, and implementation – often under accelerated timelines
- Leads the planning, deployment, and governance of role-based training curriculum across functions
- Leads the design and implementation of learning programs (refresher training, cross-training, etc.)
- Manages the day-to-day delivery of programs to ensure consistent quality and alignment to employees and their learning goals
- Drives development and review of engaging learning materials/ assessments to support learning programs utilizing multiple delivery methods
- Leads technical sessions as needed to scale eDMS/LMS capabilities

*Operational Excellence & Systems Enablement*

- Defines, monitors, and reports quality metrics and KPIs to assess system health, compliance risk, and performance trends
- Drives continuous improvement initiatives to enhance efficiency, reduce risk, and strengthen QMS robustness
- Leads the implementation, optimization, and governance of eQMS platforms, ensuring validated systems, strong user adoption, and effective lifecycle management

*Cross-Functional Leadership & Quality Culture*

- Partners with cross-functional stakeholders to embed quality into business processes and decision-making
- Communicates quality risks, dependencies, and tradeoffs with clarity and urgency, influencing outcomes without direct authority
- Contributes to building a high-performing quality organization and models a culture of accountability, transparency, and continuous improvement

**Education and Skills Requirements:**

- Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred
- 8+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred)
- Demonstrated experience with direct ownership of QMS and quality systems
- Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements
- Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems
- Strong strategic and operational capability, balancing vision-setting with hands-on execution
- Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment
- Strong judgment and risk management skills, balancing compliance, science, and business needs
- Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders
- Highly proactive, accountable, and comfortable operating with a high degree of autonomy

\#LI-Onsite

MA Pay Range

$160,000 - $195,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Director, QA GMP Operations

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance. The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview.

This is an onsite role based in Waltham, MA.

**Primary Responsibilities Include:**

- Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities.
- Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines.
- Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs.
- QA support of Tech Transfer and Process Validation activities.
- Disposition of GMP batches and interfacing with the Qualified Person (QP).
- Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts.
- Manage CDMO performance within Quality Agreement expectations and GMP compliance.
- Drive continuous improvement and inspection readiness.
- Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally.
- Adjudicate on compliance discussions and negotiate any required corrective actions.
- Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence.

**Education and Skills Requirements:**

- Minimum of a BA/BS degree
- Minimum of 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company
- Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
- Experience implementing and utilizing various outsourcing and support models
- Experience with disposition of product batches and interfacing with a Qualified Person (QP)
- Excellent written and oral communication skills, including well-developed presentation skills
- Excellent organizational skills and ability to manage multiple priorities
- Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization
- General business management knowledge to assess the impact of project decisions on financial and corporate objectives
- Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities
- Embrace Dyne’s core values and culture

\#LI-Onsite

MA Pay Range

$188,000 - $230,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Senior Director, Quality Control

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Senior Director, Quality Control leads the strategy and execution of Quality Control activities that support clinical and commercial manufacturing, pipeline advancement, and product lifecycle management. This role ensures global GMP compliance, inspection readiness, and robust analytical support across external testing laboratories, including release and stability testing.

The Senior Director partners closely with contract manufacturing and testing organizations and collaborates across Analytical and Process Development, Manufacturing, Quality Assurance, Supply Chain, Regulatory Affairs, and Project Management to advance quality and business objectives.

This position is based in Waltham, MA and is not eligible for remote work.

**Primary Responsibilities Include:**

*QC Strategy, Compliance, and Regulatory Readiness*

- Define and execute the Quality Control strategy in alignment with quality and business objectives.
- Ensure contract testing laboratories meet global GMP requirements and maintain inspection readiness.
- Represent Quality Control during regulatory inspections.
- Author, review, and approve analytical Chemistry, Manufacturing, and Controls sections of Investigational New Drug applications, Biologics License Applications, and Marketing Authorization Applications.
- Evaluate and implement effective tools for analytical data review, statistical analysis, stability assessment, and expiry assignment.
- Lead internal Specification and Stability Review Boards and facilitate clear, timely, and risk-based decisions.

*Technical and Operational Leadership*

- Lead the authoring, review, and approval of analytical method transfers, qualifications, and validations.
- Oversee external testing laboratory operations, release and stability testing, and the issuance of Certificates of Analysis.
- Review environmental monitoring, sterility, bioburden, and endotoxin data and participate in related reviews and investigations.
- Lead the establishment and revision of drug substance and drug product specifications, including the development of appropriate scientific and regulatory rationale.
- Lead Quality Control compliance activities, including change controls, corrective and preventive actions, and data integrity initiatives.
- Lead out-of-specification and out-of-trend investigations and ensure appropriate root-cause analysis, corrective actions, and timely resolution.
- Oversee the reference standard program across external testing vendors.

*Performance, Analytics, and Vendor Partnership*

- Build Quality Control capabilities in stability data analysis, biological assays, and statistical analysis to support evolving portfolio and business needs.
- Analyze laboratory performance and quality metrics and present findings, risks, trends, and recommendations in internal and vendor governance forums.
- Partner with contract manufacturing and testing organizations to align expectations, resolve complex issues, and drive reliable execution.
- Establish clear performance expectations for external laboratories and monitor execution against quality, compliance, and operational objectives.
- Apply sound judgment, situational awareness, collaboration, and negotiation skills to influence outcomes across a highly matrixed environment.
- Collaborate with internal stakeholders to anticipate analytical and Quality Control requirements for clinical development, commercialization, and lifecycle management.

*People and Organizational Leadership*

- Build and strengthen technical Quality Control capabilities to support corporate goals, pipeline advancement, and future growth.
- Recruit, coach, and mentor team members while supporting professional development and career growth.
- Establish clear priorities, promote accountability, and ensure resources are aligned with functional and organizational objectives.
- Foster an inclusive, collaborative, and high-performing team culture focused on quality, continuous improvement, and results.
- Empower team members and leaders to exercise sound judgment, take ownership of outcomes, and work effectively across functions.
- Promote transparent communication, constructive feedback, and effective collaboration with internal and external partners.

**Education and Skills Requirements:**

- Bachelor’s degree in biology, analytical chemistry, biochemistry, or a related field.
- Advanced degree in chemistry, analytical chemistry, or a related discipline is preferred.
- 15+ years of experience in Analytical Development and Quality Control, or equivalent experience, including significant leadership of people or a function.
- Strong GMP Quality Control background, including experience with compendial and product-specific assays for antibodies and small molecules.
- Strong knowledge of current Good Manufacturing Practices and applicable International Council for Harmonisation, U.S. Food and Drug Administration, and European Union regulations.
- Demonstrated experience overseeing contract testing laboratories, analytical method lifecycle activities, release and stability programs, and inspection readiness.
- Demonstrated experience supporting regulatory submissions and inspections, including the preparation and review of analytical Chemistry, Manufacturing, and Controls content.
- Experience establishing and maintaining drug substance and drug product specifications, stability programs, reference standard programs, and laboratory compliance systems.
- Strong understanding of data integrity requirements, change controls, corrective and preventive actions, and out-of-specification and out-of-trend investigations.
- Demonstrated ability to set functional direction, manage interdependencies, influence senior stakeholders, and translate strategy into execution.
- Proven ability to establish productive relationships and negotiate effectively with contract laboratories, manufacturing organizations, and other external partners.
- Excellent interpersonal, organizational, negotiation, and written and verbal communication skills.
- Ability to operate effectively in a highly matrixed, fast-paced, and evolving environment.
- Sound judgment and the ability to make decisions involving complex technical, compliance, operational, and organizational considerations.

\#LI-Onsite

MA Pay Range

$240,000 - $285,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Boston BioProducts

Quality Assurance Specialist

Boston BioProducts is seeking a Quality Assurance Specialist to support and maintain our Quality Management System (QMS) and ensure compliance with applicable quality standards and regulatory requirements. The QA Specialist is responsible for reviewing quality documentation, supporting product release activities, enssuring final products meet established quality standards, and serving as a key point of contact for vendors and customer quality-related requests. This is a 100% onsite (Mon-Fri) position based in Milford, MA- LOCAL CANDIDATES ONLY

\*\*Direct Applicants ONLY - No Staffing Agencies or Third-Party Recruiters."

Responsibilities

- Ensure products manufactured by BBP meets or exceeds customer expectations and quality standards
- Works in conjunction with the Quality team and management to maintain a Quality Management System that complies with current regulatory and industry requirements
- Review batch records and other relevant documents to ensure accuracy, completeness, and compliance with GDP and established procedures.
- Create the CoA and ensure all product specifications are accurate
- Identify and report any discrepancies observed during batch record reviews to the Quality Operations Manager
- Ensure that the product meets the specification and client criteria prior to release.
- Ensure the releasing and rejecting of materials, intermediates, packaging, and labeling materials, as applicable.
- Review In process forms, protocols, and records for adherence to Good Documentation Practices (GDP).
- Ensure that Certificate of Analysis (CoA), Safety Data Sheet (SDS), and BSE/TSE statements are obtained from vendors. Communicate with vendors as needed to obtain the necessary documentation for incoming materials.
- Coordinate with the commercial team to initiate Change Orders and Deviations related to products per customer request
- Coordinate with other departments to ensure releasing raw materials and finished goods within the timeline
- Assist the Quality Engineer with drafting, processing, investigation, and reporting of Deviations, NCRs, CAPAs and customer complaints.
- Assist in investigating and identifying the root cause using appropriate analytical techniques for NCR investigations.
- Perform QA periodic checks of all the functional area
- Ensure that CoA, BSE/TSE statements, and other documents generated within BBP are correct and delivered in a timely manner.
- Maintain Quality Records and production documentation within eQMS.
- Draft, review, and update QMS documentation as needed.
- Support internal and external audits by preparing documentation, participating in audit activities, and assisting with follow-up actions.
- Assist the Quality Operations Manager in responding to customer inquiries related to quality systems, compliance, and product documentation.

Education

- Requires a Bachelor’s degree in a scientific discipline or equivalent

Experience

- Minimum 3-5 years of relevant experience

Knowledge & Skills

- Ability to follow instructions precisely, recognize deviations, and recommend corrective action within the scope of training.
- Preferably strong knowledge of ISO 13485, ISO 9001and GMP
- Have strong written and verbal communication skills, a detail-oriented work ethic, and the ability to understand recognized regulations such as ISO and GMP.
- Ability to work independently, adhering to quality, production, and customer expectations and timelines.
- Computer literate and experienced with Microsoft Office.
- Demonstrated skills in developing and organizing systems for the management of information.
- Preferably strong knowledge of chemistry
- Demonstrate the ability to meet deadlines, multitask, and change priorities while maintaining productivity.
- Possesses well-developed attention to detail and the ability to maintain accurate records.

BioMarin Pharmaceutical Inc.

Sr. Associate, Internal Audit

Sr. Associate, Internal Audit

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin Internal Audit is committed to helping BioMarin achieve its full potential in transforming patient’s lives by minimizing overall company risk. We pride ourselves in being objective and independent of the areas we assess, while maintaining our commitment to advance the organization. We provide independent assurance to the board of directors and management. Our disciplined approach evaluates the effectiveness of BioMarin’s risk management, control and governance processes. We also assist with proactive advisory projects. An open and transparent partnership helps us develop the appropriate context and understanding of the issues at hand, minimize surprises, and drive greater value in the outcomes.

In carrying out our mission, we pledge to:

- Be a trusted partner
- Lead with integrity & enthusiasm
- Focus on what matters
- Share industry practices

As part of our mission, we also aim to provide valuable business insights (covering governance, risk, and control, and beyond), using data analytics to identify potential indicators for non-compliance, fraud and waste.

Sr. Associate, Internal Audit:

This role reports to the Head of Internal Audit\[SH1.1\], and the Sr. Associate will be instrumental in building a world-class internal audit function, a function that provides both assurance and advisory services regarding BioMarin’s governance, risk and control effectiveness, as well as a function that generates actionable business insights.

This role partners with other members of the Internal Audit team and is responsible for performing audits to evaluate the design and effectiveness of internal controls, to identify instances of non-compliance, ineffective or inefficient operations, potential fraud, waste, and abuse. In carrying out this role, you must demonstrate good business acumen and robust experience with assessing risk and conducting internal audits. You serve as a trusted partner to the business, continually staying abreast of enterprise-wide initiatives and functional strategies, to ultimately ensure that the Internal Audit portfolio of audits is aligned with key business risks.

Responsibilities

The position of Sr. Associate reports to the Head of Internal Audit. The key responsibility of this position is to support audit planning, execution, and reporting by leveraging data to perform robust analysis aimed at identifying trends, anomalies, and control weaknesses across the process/system/organization, with a focus on effectiveness, compliance and operational integrity.

1. Planning the audit

- Participate in audit scoping discussions with cross-functional teams (e.g., Finance, Operations, IT) and Audit Leadership to understand relevant risk, controls, and associated data sources supporting audit areas
- Conduct research and reference available documentation to develop the risk and control matrix to inform the audit scope.
- Develop audit planning memos memorializing the audit scope, objective and approach
- Manage the collection, review, and storage of all supporting audit documentation within the audit system

2. Conducting the Audit

- Coordinate audit interviews and process walkthrough, including the agenda, leading the discussion, and memorializing the outcomes/notes
- Creates the initial audit testing workbook detailing the key risks and controls in the process and the subsequent testing plan (and testing attributes) required to provide reasonable assurance over the design and operating effectiveness of management's controls or insights needed for decisionmakers.
- Manages outreach to stakeholders to request relevant data / system reports, and or other to support detailed analysis of control effectiveness, including the collection and review for completeness.
- Perform audit testing, analyzing available datasets to identify patterns, outliers, and potential issues related to internal policies and business processes.
- Documents conclusions from testing, including a summary of the control effectiveness, and any identified instances of non-compliance / exceptions
- Communicates results of audit testing with the Audit Leadership and respective auditees to validate the accuracy of findings by confirming no additional data /documents exist that would explain any exceptions identified
- quality self-review for accuracy, clarity, completeness, and adherence to program and audit techniques employed
- Escalate any critical audit issues appropriate management

3. Reporting Results

- Communicate issues and root causes with Audit Leadership and management of the area under audit and gain consensus on the path forward
- Draft initial materials to socialize results with auditees and department leadership

4. Other

- Participate in enterprise risk assessment activities, and conduct other audit engagements, including advisory engagements
- Maintain existing certifications and seek further certification where appropriate
- Develop and maintain dashboards and reports to monitor operational & other metrics and key risk indicators and support the development of continuous auditing and monitoring tools to proactively detect non-compliance.

Education

- Bachelor’s degree required
- One or more of: CPA, Certified Internal Auditor, Certified Information Systems Auditor, or Certified Fraud Examiner designation preferred

Relevant Experience:

- 3-5 years in internal audit, Compliance, advisory or global corporation, or a combination hereof.
- Biotech/Pharmaceutical/Life Science experience preferred.
- A strong candidate will be our “go to person” to solve problems, and get work done. Attention to quality and details, data-driven, critical thinking, and good analytical skills are essential to this role.

Essential Skills:

- Fluent & self-starter in the use of AI tools (Claude, ChatGPT, etc.)
- Highly self-motivated and able to work independently
- Proactively seeks knowledge, new tasks, and responsibilities.
- Ability to organize projects and work responsibilities.
- Prioritize effectively, and meet deadlines
- Proficiency in data analytics and visualization platforms (e.g., Databricks, Power BI).
- Experience working with ERP systems (e.g., SAP) and audit management tools.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work with ambiguity, and respond to a rapidly changing, highly innovative environment
- Exhibit professional savvy and ability to interact with various levels of management
- Excellent in developing high quality presentations, Excel formulas and data analytics

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.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

California

Associate Director, Medical Diagnostics, Rare Diseases

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

The Associate Director, Medical Diagnostics, will play a pivotal role in advancing diagnostic excellence for patients with rare genetic diseases by developing and implementing strategies that improve disease recognition, accelerate diagnosis, and optimize patient identification.

Working in the Global Medical Affairs organization, this individual will collaborate with healthcare professionals, diagnostic laboratories, public health organizations, and internal cross-functional teams to develop disease-specific diagnostic ecosystem strategies, enhance specific biomarker and genetic testing, optimize rare-disease testing and newborn screening adoption in healthcare system and identify opportunities to increase awareness of rare diseases. The role focuses on enabling earlier and accurate diagnosis through innovative diagnostic approaches, diagnostic laboratory partnerships, implementation science, and emerging technologies including artificial intelligence (AI).

The successful candidate will possess strong scientific expertise in rare diseases, genetics, health care and diagnostics, along with exceptional relationship-building skills and the ability to influence diverse stakeholders within a highly collaborative, matrixed pharmaceutical organization.

**Key Responsibilities**

**Diagnostic Strategy & Patient Identification**

- Develop and implement medical diagnostic strategies that improve identification of patients with rare genetic diseases.
- Advance biomarker and genetic testing initiatives to facilitate earlier and more accurate diagnosis.
- Drive improvements in diagnostic testing practices through multidisciplinary engagement with clinician healthcare, policy makers and laboratory partners.

**Scientific Engagement & Disease Awareness**

- Serve as a scientific resource on rare genetic diseases, biomarkers, genetic testing and diagnostic pathways.
- .
- Increase diagnostic awareness through evidence-driven approaches and stakeholder engagement.
- Deliver high-quality scientific presentations to clinicians, laboratory professionals, and other healthcare stakeholders.

**Laboratory & External Partnerships**

- Build collaborative relationships with laboratories conducting sponsored testing programs and other diagnostic partners.
- Partner with laboratory organizations to improve access to appropriate biomarkers and genetic testing.
- Collaborate with healthcare professionals, laboratory leaders, and policymakers to communicate disease-state information and support earlier diagnosis.
- Identify opportunities to enhance laboratory utilization and diagnostic testing practices.

**Innovation & Healthcare Transformation**

- Contribute to the development of AI-enabled and data-driven strategies that improve diagnostic speed, accuracy, and patient identification.
- Utilize implementation-science methodologies to improve diagnostic workflows and healthcare system adoption.
- Support initiatives leveraging electronic health records (EHRs), clinical databases, and real-world evidence to identify patients earlier in the disease journey.
- Contribute to innovative diagnostic initiatives while ensuring appropriate ethical, regulatory, and compliance standards.

**Cross-Functional Collaboration**

Partner closely within Medical Affairs, Genomics, Clinical Development, Commercial, Regulatory Affairs, Government Affairs, Patient Advocacy, and Data Science teams.

- Translate medical insights into actionable diagnostic initiatives that support broader organizational objectives.
- Operate effectively within a matrix organization while fostering collaboration across multiple functional areas.

**Qualifications**

**Required**

- Advanced degree required (MD, PharmD, or PhD) in Medicine, Pharmacy, Genetics, Molecular Biology, Biomedical Sciences, Public Health, or a related scientific discipline.
- Minimum 8 yrs experience within Medical Affairs, Diagnostics, Precision Medicine, or Rare Diseases in the pharmaceutical or biotechnology industry.
- Strong understanding of rare genetic disorders and associated diagnostic pathways.
- Demonstrated knowledge of biomarkers, molecular diagnostics, genetic testing methodologies, and biochemical marker interpretation.
- Experience collaborating with clinical laboratories, diagnostic partners, or sponsored testing programs.
- Excellent scientific communication, presentation, and stakeholder engagement skills.
- Demonstrated ability to work successfully within a cross-functional matrix organization.

**Preferred**

- Experience in rare disease therapeutics.
- Knowledge of newborn screening techniques, policies, and public health screening programs in the United States and globally.
- Experience with implementation science, real-world evidence, and healthcare data analytics.
- Understanding of variants of uncertain significance (VUS) and their clinical implications.
- Experience developing family screening or cascade testing strategies.
- Familiarity with artificial intelligence and digital health applications in diagnostics.
- Knowledge of state-based public health systems and laboratory networks.

**Core Competencies**

**The successful candidate will demonstrate:**

- Strong strategic thinking with the ability to translate scientific insights into actionable diagnostic initiatives.
- Deep clinical understanding of rare genetic diseases, biomarkers, and diagnostic pathways.
- Excellent communication and presentation skills across scientific, clinical, and executive audiences.
- Outstanding relationship-building and stakeholder management capabilities.
- Ability to educate healthcare professionals through meaningful, compliant scientific exchange.
- Strong collaboration and influence within cross-functional teams.
- High level of initiative, accountability, and execution.
- Analytical mindset with experience utilizing healthcare data to improve patient identification.
- Ability to manage multiple priorities while delivering measurable results.

**Technical Expertise**

- Rare genetic diseases
- Biomarkers and molecular diagnostics
- Genetic and biochemical assays
- Precision medicine
- Diagnostic pathways
- Sponsored testing programs
- Laboratory medicine
- Variants of uncertain significance (VUS)
- Newborn screening
- Public health screening programs
- Electronic health records (EHRs)
- Real-world evidence
- Implementation science
- Artificial intelligence in diagnostics
- Family screening and cascade testing
- Healthcare systems and referral pathways

**Success Measures**

**Success in this role will be demonstrated by:**

- Increased utilization of appropriate biomarker and genetic testing.
- Improved awareness of rare diseases among healthcare professionals.
- Earlier diagnosis and improved patient identification.
- Successful partnerships with laboratories and key healthcare stakeholders.
- Increased identification of undiagnosed or misdiagnosed patients.
- Enhanced diagnostic pathways and referral networks.
- Effective cross-functional collaboration that advances Medical Affairs objectives.
- Successful implementation of innovative diagnostic and AI-enabled initiatives that improve patient outcomes.

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.

IDEAYA Biosciences

Senior Manager, Monitoring Quality Oversight

**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 teamwork to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA. or San Diego, CA.

Position Summary:

IDEAYA is seeking a talented, experienced, and highly motivated Monitoring Quality Oversight Manger in Clinical Operations with a passion for new cancer therapy development. This role will be responsible for monitoring quality oversight across multiple studies, thus supporting the Clinical Operations team in the operational execution of IDEAYA’s clinical trials.

As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data quality and compliance within clinical operations. This role involves a proactive approach to monitoring oversight, including collaboration with CROs and internal teams to identify and mitigate risks, streamline processes, and implement best practices. The successful candidate will have a strong background in clinical operations, excellent analytical skills, and the ability to provide strategic guidance to ensure the integrity of clinical trial data.

As a member of our dynamic adhering group, you will help to grow IDEAYA’s pipeline and you will play a pivotal role in ensuring the quality and integrity of clinical trial data through effective oversight of the CRO monitors.

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

Reporting to: Senior Director, Clinical Operations

Job Description

**What you’ll do:**

- Conduct monitoring quality oversight visits across all clinical studies in North America to ensure compliance with study protocols, regulatory guidelines, and company policies.
- Generate and implement comprehensive monitoring quality oversight plans tailored to specific studies, aligning objectives with organizational goals and project timelines.
- Review and assess monitoring plans for each study, ensuring they are robust, comprehensive, and reflective of best practices in clinical monitoring.
- Evaluate monitoring reports in preparation for oversight visits, identify potential issues or trends and developing appropriate action plans for resolution to address any non-compliance or data quality concerns.
- Provide expert guidance and support to clinical operations study teams and service providers on monitoring-related matters, including but not limited to protocol deviations, adverse events, and data quality assessments.
- Conduct risk assessments regarding monitoring activities and develop risk mitigation plans to uphold the quality and integrity of clinical trial data.
- Stay updated on regulatory requirements, guidelines, and industry best practices related to monitoring oversight, ensuring their effective implementation within the organization and advising on necessary changes.
- Assist in the development and maintenance of Standard Operating Procedures (SOPs) related to monitoring oversight, ensuring adherence and compliance across all studies, and updating them as necessary.
- Collaborate with CRO monitors to ensure effective management of monitoring activities while adhering to quality standards and fostering a strong, transparent partnership.
- Maintain tracking of clinical operations monitoring report review metrics and compliance to ensure continuous improvement in monitoring oversight.
- Lead training and development initiatives for study teams and service providers to ensure a clear understanding of monitoring practices, responsibilities, and expectations.
- Prepare and present findings from monitoring oversight activities to senior management, providing insights and recommendations for enhancing the overall quality assurance framework.
- Identify potential areas for process improvement within the monitoring oversight function, implementing changes that promote efficiency, effectiveness, and compliance.
- Monitor adherence to action plans developed during oversight visits and ensure proper follow-up on corrective and preventive actions.
- Coordinate with the quality assurance team to support audits and inspections, ensuring that all documentation and processes meet required standards.

**Requirements:**

- Bachelor’s Degree in life science or equivalent combination of education, training, and relevant experience
- Minimum 6 years of relevant experience in biotech or pharmaceutical industry, of which a minimum of 3 years of focusing on monitoring oversight within a biotech or pharmaceutical setting.
- At least 3 years of experience in oncology.
- Experience in Clinical Operations and a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
- Strong understanding of clinical trial processes.
- Proven experience in managing CRO relationships and overseeing monitoring activities.
- Self-motivated, with initiative and able to take ownership of, and follow through with, specific tasks.
- Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships.
- Exceptional analytical skills, with the ability to assess data and trends effectively.
- Ability to exercise good judgment and make decisions that are appropriate for IDEAYA.
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment.
- Excellent communication and interpersonal skills, with the ability to provide clear guidance and support to cross-functional teams.
- Analyze and triage problems, prioritize accordingly, and propose solutions.
- Strive for continuous improvement and embrace innovative ideas in daily work.
- Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines.
- Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Adobe Acrobat), clinical trial management systems, data management tools and experience with Smartsheet is a plus.
- Ability to travel up to 80%.

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

**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 Senior Manager, Monitoring Quality Oversight is $168,000 - $208,000. 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.

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.

We are committed to providing reasonable accommodation to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.

AbbVie

Associate, Study Management III/CTM III

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

As a Study Management Associate III, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team.

The Study Management Associate III works as an independent, contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 clinical trials under the guidance of the Study Project Manager and SMA Manager. The Study Management Associate III works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives. The Study Management Associate III is expected to work in accordance with all AbbVie Ways of Working.

This is a global role and may be located virtually.

Responsibilities

- The Study Management Associate III is expected to work independently as a clinical study leader and contributor with appropriate support from the Study Project Manager on the following activities in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures):
- Study-level oversight and leadership of one or more global trials in a cross-functional environment for activities from inception through closure, connecting functional work and strategic work across the global study, including but not limited to:
- o Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including strategy development, meeting facilitation, and timely documentation at the study level to drive for timely execution of clinical trial(s)
- o Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for one or more external vendors, e.g., central lab, recruitment, imaging, internal and external committees
- o Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention
- o Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing. o Ensure inspection readiness and participate in related activities. Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.
- Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to:
  o Protocols, regulatory submissions, patient reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders
  o CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
- o EDC, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and oversight. Management of investigational product and other associated study supplies.
- Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors. Support global submission strategies. Support process improvement initiatives or serve as a subject matter expert and/or mentor

Qualifications

- Bachelor’s Degree or OUS equivalent required
- Must have at least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies
- Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
- Experienced user of systems such as EDC, IRT, CTMS, and eTMF
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study.
- Excellent organizational and time management skills, strong attention to detail.
- Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written)
- Proactive, collaborative mindset
- Ability to work independently in a fast-paced global team environment
- Preferred: Exposure to study initiation through completion activities; global study exposure

Additional Information

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>)

Other Non-US

Nurix Therapeutics

Senior Manager, External Quality-Supply Chain

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

**About the Position:**

The Senior Manager, Supply Chain Quality Assurance is responsible for ensuring the quality and compliance of materials, products, and distribution activities throughout the global supply chain. This position provides quality oversight of contract manufacturers, suppliers, warehouses, packaging operations, depots and logistics providers to ensure compliance with applicable GMP, GDP, GCP (where applicable) and company quality standards.

This role partners with Supply Chain, Manufacturing, Regulatory Affairs, Technical Operations, Clinical, CMC, and external business partners ensuring the quality, compliance, and timely supply of clinical materials across Nurix’s pipeline programs.

Reporting to the Senior Director, Quality Assurance, the Senior Manager will apply sound independent judgment to drive timely identification, investigation, and resolution of quality events, while building a culture of continuous improvement and cross-functional collaboration.

**Responsibilities:**

- Provide Quality oversight of global supply chain operations supporting early and late-stage clinical programs.
- Ensure quality requirements are incorporated into procurement, manufacturing, packaging, storage, transportation and distribution activities.
- Oversee quality aspects of warehousing and distribution operations.
- Qualify, monitor, and maintain approval status of suppliers, CMOs, laboratories depots and logistics providers.
- Participate in supplier audits and quality risk assessments.
- Manager supplier quality agreements and ensure periodic review.
- Ensure compliance with Good Distribution Practices.
- Oversee qualification of shipping lanes and transportation providers.
- Review shipping validation documentation.
- Assess quality impact of shipping deviations through the review of shipping deviations, including review of temperature excursion investigations and product impact assessments.
- Identify continuous improvement opportunities to simply quality processes while maintaining compliance.
- Maintain current knowledge of evolving regulatory expectations and industry standards; translate requirements into practical operational guidance for the organization.

**Required Qualifications:**

- Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, engineering or a related
- 5+ years of progressive Supply Chain or Supply Chain Quality Assurance experience in the pharmaceutical or biopharmaceutical industry with global distribution activities.
- Demonstrated experience managing and directing activities of outsourced manufacturing, testing, packaging and labeling and distribution operations.
- Thorough knowledge of FDA regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q8, Q9, Q10, Q11), and EudraLex - Volume 4 - Good Manufacturing Practice (GMP) and their practical application to CMC development.
- Proven track record managing quality events, deviations, CAPA programs, and change control in a clinical or commercial pharmaceutical setting.
- Experience supporting regulatory agency inspections (FDA, EMA, or equivalent).
- Excellent project management skills with the ability to manage multiple high-priority deliverables simultaneously.
- Strong verbal and written communication skills; able to present complex quality and compliance topics clearly to diverse stakeholders.
- Willingness to travel to CDMO and laboratory sites domestically and internationally, as

**Preferred Qualifications:**

- Experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization.
- Experience with electronic QMS platforms (e.g., Veeva Vault) and document management
- Expertise in both development-phase and pre-commercial-phase quality assurance standards and expectations.

**Salary:** $173,000 - $199,00

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**Senior Director, Quality Control**

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

**Position Description**

Nurix Therapeutics is seeking an experienced Senior Director, Quality Control to join the Analytical Development and Quality Control group. This individual will establish and lead a QC operational function, establishing operations, systems, and a team to support programs from CMC development through commercial manufacturing.

The ideal candidate brings deep expertise in small molecule QC, strong regulatory acumen, and proven experience managing external CDMO and CTL relationships. This role will represent QC in health authority inspections and audits, and will work cross-functionally with Quality, Analytical Development, and Manufacturing to ensure product quality and patient safety across the portfolio.

**Key responsibilities**

- Build and lead the QC function: Establish QC systems and infrastructure; recruit, manage, and mentor internal QC staff and contractors
- Set QC strategy across the product lifecycle: Define and execute QC strategy spanning CMC development through commercial programs, ensuring alignment with company milestones and submission timelines
- Oversee QC operations internally and externally: Direct method validation, release and stability testing, data review, deviations, investigations, change control, and CAPA internally and at CDMOs, and CTLs
- Identify and manage quality risk: Proactively identify, assess, and escalate risks related to patient safety, product quality, shelf life, supply continuity, or GMP compliance; drive risk mitigation strategies in partnership with Analytical Development, Quality, and Manufacturing functions
- Lead QC through audits and inspections: Serve as QC lead during health authority inspections and internal audits; collaborate with Quality to conduct audits of GMP manufacturing and testing sites, including CDMOs and CTLs
- Support regulatory submissions and health authority interactions: Contribute to global regulatory filings; collaborate on responses to health authority information requests, regulatory commitments, and post-approval changes
- Direct stability programs: Develop and execute stability strategy in collaboration with Analytical Development leads, ensuring alignment with ICH guidelines and regional regulatory requirements
- Manage reference materials and retains: Oversee qualification and inventory of reference standards; develop sampling plans and manage sample retain programs
- Drive continuous improvement: Identify and implement process improvements, data integrity enhancements, and quality system upgrades (e.g., eQMS) to support a scalable, inspection-ready QC organization
- Travel up to 15% to CDMO, CTL, and manufacturing sites and supplier and scientific conferences

**Qualifications**

- Advanced degree in Chemistry, Pharmaceutics, Chemical Engineering, or related discipline. BS/MS with 16+ years of relevant experience, or PhD with 14+ years of relevant experience
- 5+ years in a QC leadership or management role, with demonstrated ability to build and mentor teams
- Deep experience in small molecule pharmaceutical development, including method lifecycle management and oversight of validation, release, and stability operations
- Proven experience managing external manufacturing and testing operations at CDMOs and CTLs
- Expertise with analytical methods such as HPLC, GC, dissolution, and microbiological testing
- Direct experience leading through health authority inspections and internal audits and conducting audits of manufacturing and testing sites.
- Deep working knowledge of cGMP, ICH guidelines, and USP/EP/JP compendial standards
- Experience contributing to global regulatory filings and health authority correspondence (e.g., responses to information requests, post-approval changes)
- Strong interpersonal and cross-functional collaboration skills, with the ability to influence and build consensus across Quality, Supply Chain, Analytical Development, and Manufacturing functions

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**Salary Range:** $280,200 - $319,800

**Location:**  Woodlands TX or Brisbane, CA - Onsite

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

Florida

Eli Lilly and Company

Senior Maintenance Technician - Medicine Foundry

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

**Organization and Position Overview**

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

The Senior Maintenance Technician is a multi-craft maintenance position that requires expertise in various mechanical, electrical, and instrumentation disciplines. The Lead Technician will be responsible for overseeing the maintenance and repair of manufacturing and facilities equipment throughout the site, ensuring optimal performance and minimal downtime supporting the Utilities, Tank Farm, Warehouses, facilities and admin areas at the Foundry. This role involves performing routine maintenance, troubleshooting, and repairs to ensure the facility operates efficiently and complies with all regulatory standards.

**Key Responsibilities:**

- Safety: Conduct daily activities with a safety-first mindset. Ensure compliance with safety regulations and company policies during all maintenance activities.
- Compliance: Complete all work in a timely manner and in accordance with GMP (Good Manufacturing Practices) procedures.
- Documentation: Complete all documentation associated with daily maintenance activities, including work order completion and post maintenance documentation.
- Communication: Responsible for passing off vital information to all appropriate parties related to critical equipment issues both through oral and written communication methods.
- Ability to work independently and collaboratively, including leading a team of mechanics and technicians in performing preventive and corrective maintenance on manufacturing equipment.
- Possess strong aptitude to troubleshoot and repair mechanical, electrical, and instrumentation issues to ensure continuous operation of production lines.
- Lead in the execution of maintenance procedures to maximize equipment reliability and efficiency.
- Collaborate with engineering and production teams to identify and resolve equipment-related issues.
- Maintain accurate records of maintenance activities, including work orders, equipment history, and spare parts inventory.
- Provide training and guidance to team members to enhance their technical skills and knowledge.
- Participate in continuous improvement initiatives to enhance equipment performance and reduce maintenance costs.
- Champion for support of planning and scheduling including feedback to planners for continuous improvement.
- Willingness to volunteer and support committees/teams outside of primary role (safety, continuous improvement…etc.)
- Common Equipment the Lead Mechanic will be responsible for:
  - Process pumps (centrifugal, positive displacement, and turbine pumps) include troubleshooting, dismantling and reassembly.
  - Boilers, Air compressors, softeners, heat exchangers, including troubleshooting, maintenance and reassembly.
  - HVAC Equipment, Including troubleshooting, maintenance and reassembly.
  - General maintenance and repairs within Facilities admin spaces

**Basic Requirements:**

- High school diploma or equivalent.
- Minimum of 5 years of experience in a multi-craft maintenance role within a pharmaceutical or manufacturing environment.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Associate’s degree or technical degree or certification in a related field is preferred.
- Minimum of 5 years of experience in a multi-craft maintenance role within a pharmaceutical or manufacturing environment.
- Proficient use of CMMS (Maximo) and other Work Order systems.
- Proficient use of electronic devices, smartphones, tablets, and laptops.
- Strong knowledge of mechanical, electrical, and instrumentation systems.
- Proven leadership and supervisory skills.
- Excellent troubleshooting and problem-solving abilities.
- Ability to read and interpret technical drawings, schematics, and manuals.
- Effective communication and interpersonal skills.

**Additional Information:**

- Initial location: Lilly Technology Center, Indianapolis, or Parkwood West, Carmel, Indiana. Permanent location: in Lebanon, IN.
- This role will start as an 8-hour, Monday–Friday position and will later transition to a 12-hour day shift on a 2-3-3-2 schedule.
- Tasks require entering manufacturing areas which require wearing appropriate PPE.
- May be required to provide support outside of normal working hours including nights, weekends, and holidays.

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

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

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

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

$21.63 - $42.31

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

\#WeAreLilly

Indiana

Expert Maintenance Electrician - Lilly Medicine Foundry

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

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

The Expert Maintenance Electrician is a skilled maintenance position responsible for installing, troubleshooting, diagnosing, and repairing electrical equipment, controls, and utility systems across the Lilly Medicine Foundry. This role supports areas site-wide, ensuring optimal equipment performance and minimal downtime while maintaining compliance with all regulatory and safety standards. As an experienced member of the electrical team, this individual also provides training and technical guidance to team members, helping build electrical expertise across the site.

**Key Responsibilities:**

- Install, troubleshoot, diagnose, and repair electrical equipment, controls, and utility systems across buildings site-wide to meet internal and external customer needs while minimizing manufacturing and facility downtime.
- Perform installation, preventive maintenance, troubleshooting and repair of electrical systems ranging from 12VDC control circuits to 480VAC power distribution and equipment systems.
- Perform operation and lockout/tagout of electrical distribution equipment rated up to 12,470V.
- Comply with all HSE requirements, support departmental safety plans, meet annual PSM goals and targets, participate in Safety Improvement activities, and report all injuries, safety concerns, and incidents to supervision.
- Read and interpret electrical schematics and P&ID drawings, and maintain qualification to perform required duties including LOTO, lift operations, and respirator use.
- Document all work in accordance with Good Documentation Practices, and partner with Supervisor and Planner/Scheduler to create and continuously improve Job Plans, ESIs, and procedures.
- Respond to electrical issues and prioritize work across buildings based on operational impact and urgency, coordinating with Operations and Maintenance to minimize disruption.
- Operate GMARS daily for work order searches, closing note entry, desktop requisitions, parts searches, and data integrity verification, and use Microsoft Office, Workday, and Performance Management tools to support personal and organizational objectives.
- Support cross-functional communications across Maintenance, Engineering, Operations shifts, Automation, and site customers to keep stakeholders informed of issues with potential impact to their areas.
- Maintain 100% compliance with self-study and Qualified Employee Program training requirements, and proactively report overdue leader-led training to supervision.
- Provide training and guidance to team members to enhance their technical skills and knowledge.

**Basic Requirements:**

- High school diploma or equivalent.
- Journeyman’s card or equivalent
- Able to lift up to 40 lbs., work in awkward positions, cramped quarters, and on ladders or scaffolding
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Prior work maintaining electrical and utility systems in a regulated manufacturing environment.
- Proficient in reading and interpreting electrical schematics, P&IDs, and technical documentation.
- Proficient in verbal and written communication with both technical and non-technical personnel.
- Willingness to maintain a strong commitment to cGMP principles, with particular emphasis on documentation quality.
- Associate’s degree in Electronics Technology or equivalent

**Additional Information:**

- This role is for The Lilly Medicine Foundry in Lebanon, IN.
- Tasks require entering manufacturing areas which require wearing appropriate PPE.
- May be required to provide support outside of normal working hours including nights, weekends, and holidays.

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

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

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

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

$21.63 - $42.31

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

\#WeAreLilly