Associate Director, Quality Control Compliance

Role: Associate Director of QC Compliance overseeing GMP lab compliance for large and small molecule manufacturing at the Hopewell, NJ site. Responsibilities: develop and implement QC compliance programs, lead investigations for OOS/OOT/OOE results, prepare compliance documentation, manage internal and external GMP audits, collaborate with QA, Regulatory, Manufacturing, and other departments to ensure regulatory adherence, and foster a culture of quality and continuous improvement. Manage and mentor a team of 1-2 QC compliance professionals, guiding training and performance. Requirements: Bachelor's degree with 8+ years in FDA-regulated biotech/pharma environment, 5+ years of managerial experience, extensive knowledge of cGMP/EU GMP for large molecules, strong leadership, analytical, and communication skills. Preferred: Master’s degree, experience with Veeva and LIMS, and previous compliance leadership. HighValue: GMP compliance, laboratory investigations, deviation management, regulatory documentation, large molecule manufacturing, cGMP standards, FDA/EU regulations, leadership in a biotech setting. WorkSetup: on-site in Hopewell, NJ; travel approximately 20%.