Director Product Quality Leader

AstraZeneca plc; Santa Monica (CA); On-site; USD 168,000 - 251,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Retirement programs

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca GmbH in Santa Monica, CA is seeking a Cell Therapy Product Quality Leader to own end-to-end quality strategy for autologous, allogeneic, and in-vivo cell therapies from clinical to commercial stages.

This role partners with Regulatory, Process Development, Analytical Sciences, Supply Chain, and other functions to ensure CGMP compliance, product stability, and lifecycle management, including authoring CMC sections and supporting health authority inspections.

Qualifications

• Bachelor’s or MS/PhD in Life Sciences or Engineering.
• 10+ years in biotech/biopharma with CGT or biologics leadership.
• Deep understanding of global cGMP regs (FDA, EMA, ICH).
• Authoring CTD sections for IND, BLA/MAA, and post-approval submissions.
• Expertise in analytical method validation, process development, tech transfer, and viral vectors.
• Experience in designing product & process control and comparability strategies.
• Ability to articulate complex technical concepts to cross-functional and regulatory audiences.
• Success in fast-paced, matrixed environments with stakeholder influence.

Responsibilities

• Serve as the Quality representative on the CMC team and lead the PQT sub-team.
• Be the single voice of Quality liaising with the CMC Program Lead.
• Develop and implement the overall Product Quality Strategy and phase-appropriate control strategies.
• Own and maintain lot release and stability specifications for CGT modalities.
• Manage the full specification lifecycle from clinical to post-approval.
• Support design and execution of analytical comparability studies.
• Support process transfer and analytical method transfer protocols.
• Oversee the stability program with Global Stability collaboration.
• Oversee annual product reviews for commercial products.
• Maintain the Product Quality Risk Register.
• Work cross-functionally to develop platform approaches for specs and stability.
• Author and review CMC sections for global filings; respond to health authority queries.
• Stay current on emerging processes & analytical technologies and regulatory expectations.
• Partner with Process Development, Analytical Sciences, Supply Chain, Quality, Regulatory, Program Management.
• Act as SME during health authority inspections (FDA, EMA).
• Review major process changes for product safety and efficacy.

Skills

Quality leadership

CMC liaison

Regulatory knowledge

GMP / cGMP knowledge

Product quality strategy

Tech transfer

Analytical methods

Cross-functional collaboration

Inspection readiness

Education

Life sciences or engineering degree

MS/PhD preferred

Job description

The Cell Therapy Product Quality Leader (PQL)is a matrixed leaderresponsible forthe end-to-end product quality strategy and lifecycle management of autologous, allogeneic, and in-vivo cell therapy products. This role will provide technical and compliance oversight for advanced therapeutic modalities, including, but not limited to, drug substance, drug product, viral delivery systems (e.g.LVV, AAV), and gene-edited cell therapy products from clinical stage through commercialization. This role requires deep technical and complianceexpertise, strategic thinking, and cross-functional collaboration to ensure product quality, regulatory compliance, and lifecycle continuity are met andmaintained.

This PQL position can physically reside at either the Gaithersburg/Rockville, MD site or Santa Monica/Tarzana, CA site locations, with an understanding that the products supported are manufactured at the Santa Monica/Tarzana, CA sites.

Main Responsibilities

• Serve as the Qualityrepresentativeon the CMCTeamandlead the Product Quality Team (PQT)sub-team

• Serve as the single voice of Quality in liaising with the CMC ProgramLeadto communicate Quality deliverables, risks, changes, etc.

• Develop and implement the overallProduct Quality Strategyand phase-appropriate control strategies

• Ownandmaintainlot release and stability specifications for advanced cell therapy modalities

• Manage the full specification lifecycle-fromclinicalstage through commercial approval and post-approval maintenance

• Supportthe design and execution of analytical comparability studies supporting process and product changes for advanced cell therapy modalities; ensure scientifically sound strategies and data-driven conclusions

• Support the design and execution of process tech transfer and analytical method transferprotocols/reports for advanced cell therapy modalities

• Oversee the stability programfor advanced cell therapy modalities, in collaboration with Global Stability

• Oversee annual product reviews for commercial products

• Maintain theProduct Quality Risk Registertoidentify, mitigate, and elevate issues related to manufacturing, analytical methods, or supply chain

• Work cross-functionallyto develop and implement platform approaches for specifications, comparability, and stability to enable consistent, scalable practices across multiple cell therapy products

• Author and review CMC sections for global filings, includingINDs, BLAs, and MAAs; manage responses to health authority queries

• Stay current on emergingprocess &analytical technologies and evolving regulatory expectations

• Partner closely with Process Development,Analytical Sciences, Supply Chain,Quality, Regulatory Affairs, Program Management, and other impacted stakeholders to ensure alignment with development milestones and commercial objectives

• Acts as a Subject Matter Expert (SME) during health authority inspections (e.g., FDA, EMA) for productquality-specificinquiries

• Review and evaluate major process changesto ensure noimpacttoproduct safety and efficacy

Education, Qualifications, & Experience

• Bachelor’s or Advanced degree (MS/PhD preferred) in Life Sciences or Engineering (e.g., Biology, Biochemistry, Chemical Engineering)

• 10+ years in the biotechnology or biopharmaceuticalindustry, with at least 3-5 years in aCell & Gene Therapy (CGT)orBiologics leadership role

• Deep understanding of globalcGMP regulations(FDA, EMA, ICH)includingphase-appropriate requirements for clinical vs. commercial products

• Demonstratedrecord of authoring CTD sections for IND, BLA/MAA, and/orpost-approval submissions

• Expertisein analytical method validation, process development, tech transfer, and viral vectors (e.g.LVV)

• Expertisein designing and executing product& processcontrol and comparability strategies

• Demonstratedability to clearly articulate complex technical concepts to cross-functional, senior management,and regulatory audiences

• Demonstrated success in a fast-paced, matrixed environment with a collaborative, problem-solving mindset, including anability to influence diverse stakeholders and drive decision-making without direct authority

The annual base pay for this position ranges from $167,595.20 - 251,392.80. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

17-Aug-2026

Closing Date

03-Sep-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.