Director Product Quality Leader

About this 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 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.

Main 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  

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 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  

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.

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