Sterility Assurance Program Manager

Role: Sterility Assurance Program Manager overseeing aseptic processing, sterilization, and contamination control in GMP manufacturing. Responsibilities: develop, implement, and improve sterility assurance policies; lead validation activities including media fills, sterilization, and environmental monitoring; manage risk assessments, deviations, and CAPA; ensure compliance with FDA, EMA, USP, ISO standards, especially EU GMP Annex 1; train personnel and support regulatory inspections. Requirements: Bachelor's in Microbiology, Biology, or Engineering; 5+ years in sterility assurance or GMP quality roles; deep knowledge of aseptic processing, sterilization methods, microbiological testing, validation, and risk management; experience with EU GMP Annex 1 and regulatory standards; strong analytical, communication, and project management skills. Preferred: experience with sterile dosage form manufacturing, electronic QMS, advanced scientific degrees. Work setup: onsite in GMP environments; may include standing, lifting 40-50 lbs, and exposure to bioprocessing materials; occasional extended hours. Overall, a senior role requiring proven expertise in contamination control and sterile manufacturing compliance within biologics or sterile drug product environments.