Director, Manufacturing Compliance (Fill/Finish)

Role: Director of Manufacturing Compliance specializing in Fill/Finish aseptic biologics GMP manufacturing. Objectives: lead and develop the compliance organization, ensure inspection readiness, and serve as the primary interface between manufacturing and quality/regulatory bodies. Responsibilities: oversee Change Control, Investigations, CAPA, monitor KPIs, handle escalations, represent manufacturing in audits and governance forums, and collaborate with cross-functional teams including Quality, Regulatory, Engineering, and Supply Chain. Requirements: BS/BA in sciences or engineering, 12+ years in biopharma, extensive GMP experience in aseptic biologics, with a focus on compliance functions like Change Control, Investigations, CAPA; deep knowledge of FDA/EMA regulations; proven leadership in multi-tiered QMS environments; strong communication skills. Preferred: multiproduct facility experience; experience with health authority interactions. High-Value: biologics, aseptic GMP manufacturing, compliance leadership, inspection readiness, cross-functional collaboration, multi-regulatory agency interaction. Work Setup: on-site in East Greenbush, NY, with standard full-time hours.