Director, Product Quality Leader (PQL)

Role: Serve as a technical quality expert within the CMC team for biologics or drug products during clinical development through post-commercialization. Responsibilities: lead product quality strategies, manage quality-related risks, develop specifications and comparability protocols, review regulatory submissions, and oversee quality commitments. Collaborate with cross-functional teams to ensure robust product quality and compliance throughout all lifecycle stages. Requirements: BA/BS in life sciences with 12+ years in regulated biopharma, including biologics development, clinical and commercial support; strong knowledge of cGMP, regulatory guidelines, and quality systems. Preferred: experience with combination products, regulatory submissions, and international standards. High-Value: biologics, gene/cell therapies, post-market oversight, quality strategy development, risk management, and cross-functional leadership in a global biotech environment. Work setup: Periodic travel; location not specified but expected to be in a regulated, collaborative setting.