Associate Director, Sterility Assurance

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.

• 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

• 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

• 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

• biologics (large molecules), sterile manufacturing, contamination control, regulatory inspection readiness, and risk assessment

on-site in Hopewell, NJ; travel approximately 10%