Director Product Quality Leader

The Cell Therapy Product Quality Leader (PQL) is a matrixed leader responsible 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 compliance expertise, strategic thinking, and cross-functional collaboration to ensure product quality, regulatory compliance, and lifecycle continuity are met and maintained.

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.

• 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 Program Leadto communicate Quality deliverables, risks, changes, etc.

• Develop and implement the overall
  
  Product Quality Strategy and 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

• 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 Registertoidentify, mitigate, and elevate issues related to manufacturing, analytical methods, or supply chain

• Work cross-functionally to 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 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 changesto ensure noimpacttoproduct safety and efficacy

• 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 biopharmaceutical industry, with at least 3-5 years in aCell & Gene Therapy (CGT) or Biologics leadership role

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

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

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

• Expertise in designing and executing product& processcontrol and comparability strategies

• Demonstratedabi…