Director Product Quality Leader

Role: Cell Therapy Product Quality Leader overseeing quality strategy and lifecycle management for autologous, allogeneic, and in-vivo cell therapy products from clinical to commercial stages. Responsibilities: serve as Quality representative on CMC teams, develop product quality strategies, maintain lot release and stability specifications, support analytical comparability and tech transfer, oversee stability programs and product reviews, author and review regulatory submissions, and act as SME during inspections. Collaborate cross-functionally with Process Development, Analytical Sciences, Regulatory, Supply Chain, and others to ensure compliance, consistency, and product integrity. Requirements: Bachelor’s or higher in Life Sciences or Engineering, 10+ years in biotech/pharma, with 3-5 years in Cell & Gene Therapy or biologics leadership, deep knowledge of cGMP regulations (FDA, EMA, ICH), experience authoring CTD sections, expertise in analytical validation, process transfer, viral vectors (e.g., LVV), and control strategies. Preferred: advanced degrees (MS/PhD), demonstrated success in fast-paced, matrixed environments, strong communication skills for technical and regulatory audiences. High-Value: focus on advanced cell and gene therapy modalities, from clinical to commercial phases, with responsibilities spanning regulatory filings, process validation, and inspections. Work setup: locations in Gaithersburg/Rockville, MD or Santa Monica/Tarzana, CA, with support for manufacturing sites in California.