Sterility Assurance Lead – Quality Assurance

About the Role
We are looking for an experienced Sterility Assurance Lead to serve as the site’s technical authority for sterility assurance, aseptic processing, and contamination control. This is a senior role within the Quality organization with direct impact on patient safety, product quality, and FDA inspection readiness.
Key Responsibilities
• Lead and continuously improve the site Sterility Assurance Program and Contamination Control Strategy (CCS)
• Serve as site SME for sterility assurance, aseptic processing, and contamination control
• Provide expert oversight of aseptic manufacturing and filling operations
• Lead EM/PM trending, excursion investigations, and contamination root cause analysis
• Support media fill strategy, execution, and investigation
• Assess aseptic practices, cleanroom behavior, and contamination risks
• Support sterility assurance–related deviations, CAPA, change controls, and risk assessments
• Oversee cleaning and disinfection effectiveness
• Support F

דרישות:

• B.Sc. in Microbiology, Biology, Biotechnology, Pharmacy, Biochemistry, Chemical Engineering, or a related life science discipline
• M.Sc. / PhD – preferred
• 5–7+ years in sterile pharmaceutical manufacturing, aseptic processing, QA sterile operations, or sterility assurance
• Hands-on GMP experience with aseptic operations, contamination control, environmental monitoring, media fills, deviations, investigations, and regulatory inspections
• FDA / EMA inspection experience – highly preferred