Director Product Quality Leader
About The Position
The Cell Therapy Product Quality Leader (PQL) is a matrixed leader responsible for the 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 compliance expertise , strategic thinking, and cross-functional collaboration to ensure product quality, regulatory compliance, and lifecycle continuity are met and maintained . This role will support multiple clinical manufacturing facilities at AstraZeneca’s Santa Monica, CA and Tarzana, CA locations
Requirements
- Bachelor’s or Advanced degree (MS/PhD preferred) in Life Sciences or Engineering (e.g., Biology, Biochemistry, Chemical Engineering)
- 10+ years in the biotech nology or biopharmaceutical industry, with at least 3 - 5 years in a Cell & Gene Therapy (CGT) or B iologics leadership role
- Deep understanding of global cGMP regulations (FDA, EMA, ICH) including phase-appropriate requirements for clinical vs. commercial products
- Demonstrated record of authoring CTD sections for IND, BLA/MAA, and /or post-approval submissions
- Expertise in analytical method validation, process development, tech transfe r, and viral vectors ( e.g. LVV)
- E xpertise in designing and executing product & process control and comparability strategies
- Demonstrated ability 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 an a bility to influence diverse stakeholders and drive decision-making without direct authority
Responsibilities
- Serve as the Quality representative on the CMC T eam and lea d the Product Quality Team (PQT) sub-team
- Serve as the single voice of Quality in liaising with the CMC Program Lead to communicate Quality deliverables, risks, changes, etc.
- D evelop and implement the overall Product Quality Strategy and phase-appropriate control strategies
- Own and maintain lot release and stability specifications for advanced cell therapy modalities
- Manage the full specification lifecycle - from clinical stage through commercial approval and post-approval maintenance
- Support the 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 transfer protocols/reports for advanced cell therapy modalities
- Oversee the stability program for advanced cell therapy modalities, in collaboration with Global Stability
- Oversee annual product reviews for commercial products
- Maintain the Product Quality Risk Register to identify , mitigate, and escalate issues related to manufacturing, analytical methods, or supply chain
- Work cross-functionally to d evelop 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, including INDs, BLAs, and MAAs; manage responses to health authority queries
- Stay current on emerging process & 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 product quality -specific inquiries
- Review and evaluate major process changes to ensure no impact to product safety and efficacy
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
5,001-10,000 employees
