Senior Director, Quality Control

Role: Senior Director of Quality Control overseeing analytical and GMP compliance activities supporting clinical and commercial manufacturing for biopharma therapeutics targeting neuromuscular and CNS disorders. Responsibilities: develop and execute QC strategies, ensure inspection readiness, author and review regulatory submissions (INDs, BLAs), oversee external testing laboratories, lead review boards, manage analytical method transfers, validations, and stability programs, and drive continuous improvement and data integrity initiatives. Collaborate across manufacturing, development, regulatory, and external vendors to ensure product quality and compliance. Lead and mentor QC teams, establish performance metrics, and foster a high-performance culture. Requirements: Bachelor's in biology, chemistry, or related; advanced degree preferred; 15+ years in analytical development/QA with strong GMP background, experience with antibodies and small molecules, and regulatory inspection support. Proven leadership in establishing specifications, stability, reference standards, and supplier oversight. Skilled in data integrity, change controls, and cross-functional influence. High-value biopharma specifics: focus on biologic and small molecule therapeutics, regulatory submission experience, GMP compliance, and external lab partnerships. Location: Waltham, MA, onsite; no remote work indicated.