Associate Director, GMP Quality

Role: Associate Director, GMP Quality Assurance, leading quality oversight for biologics manufacturing, testing, and packaging to ensure compliance with global GMP regulations. Responsibilities: review and approve GMP documents, support investigations of deviations and OOS/OOT results, conduct internal audits, qualify external suppliers and CDMOs, maintain quality agreements, and prepare for regulatory inspections. Focuses on integrating AI technologies to enhance QA processes. Requirements: Bachelor's in Chemistry, Biology, Engineering, or Pharmaceutical Sciences; 10+ years in GMP QA within biologics/large-molecule manufacturing; deep knowledge of FDA, EMA, ICH standards; strong communication, documentation, and leadership skills; experience with CMO oversight or virtual manufacturing models. HighValue: biologics, large-molecule GMP manufacturing, quality investigations, supplier qualification, regulatory compliance, AI integration. WorkSetup: hybrid NYC/Boston; willingness to relocate or commute. Travel: not specified.