Director, QA GMP Operations

Role: Director of QA GMP Operations overseeing global external and internal GMP quality for clinical and commercial manufacturing in a biopharma setting focused on neuromuscular and CNS therapeutics. Responsibilities: manage GMP quality activities including deviation investigations, batch record reviews, regulatory document assessments, tech transfer support, batch disposition with Qualified Persons, change management, and ensuring GMP compliance at CDMOs; drive continuous improvement and inspection readiness; collaborate cross-functionally to prepare for regulatory inspections and product launches, and foster a quality-focused culture. Requirements: BA/BS, 10+ years in GMP Quality Operations within late-stage or commercial biotech; leadership experience managing cross-functional teams; expertise with batch disposition, QP interface, and regulatory documentation; strong communication, organizational, and stakeholder management skills. High-Value: GMP quality oversight, CDMO management, batch disposition, regulatory compliance, late-stage clinical and commercial manufacturing, biologics or advanced modalities, process validation, and inspection readiness. WorkSetup: onsite in Waltham, MA.