Director Product Quality Leader

About the role

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 provides technical and compliance oversight for advanced therapeutic modalities, including drug substance, drug product, viral delivery systems (e.g., LVV, AAV), and gene-edited cell therapy products from clinical stage through commercialization. The 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.

Responsibilities

• Serve as the Quality representative on the CMC Team and lead 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.
• Develop 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 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, 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
• Act 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

Requirements

• 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 a Cell & Gene Therapy (CGT) or Biologics 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 transfer, and viral vectors (e.g., LVV)
• Expertise 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 ability to influence diverse stakeholders and drive decision-making without direct authority

Pay

The annual base pay for this position ranges from $167,595.20 to $251,392.80. Positions offer eligibility for various incentives, including short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.

Benefits

• Qualified retirement programs
• Paid time off (vacation, holiday, and leaves)
• Health, dental, and vision coverage in accordance with the terms of the applicable plans