Associate Director, Sterility Assurance

Role: Associate Director of Sterility Quality Assurance at a biopharma site, leading the sterility assurance and contamination control programs to ensure compliance with cGMP, FDA, and global standards. Responsibilities: oversee aseptic processing, environmental and personnel monitoring, cleaning, sterilization, and process validation; lead investigations of sterility-related events; assess contamination risks and develop mitigation strategies; serve as the subject matter expert during inspections, audits, and technology transfers; develop and review policies and protocols; provide technical leadership and mentorship within the sterility assurance team. Requirements: Bachelor's degree with 8+ years in microbiology or biological QA, preferably in large molecule sterile manufacturing within an FDA-regulated biotech/pharma environment; experience with regulatory inspections, contamination control strategies, and biologics manufacturing. Preferred: Master’s degree and extensive knowledge of cGMPs, environmental monitoring, and sterilization validation; strong technical judgment, communication, project management, and leadership skills; familiarity with biologics, IND/IMPs, and global regulatory expectations. HighValue: biologics (large molecules), sterile manufacturing, contamination control, regulatory inspection readiness, and risk assessment. WorkSetup: on-site in Hopewell, NJ; travel approximately 10%.