Head of Sterility Assurance and Contamination Control
Core
Set global strategy and standards for sterility assurance and contamination control across a worldwide network of biopharma manufacturing sites to ensure patient safety and reliable supply.
Role type
Senior leadership (Head of Sterility Assurance and Contamination Control)
Builds
Global sterility assurance systems, contamination control strategies, aseptic processing standards, and inspection-ready quality frameworks.
Domain
Biopharmaceutical manufacturing (sterile drugs, rare disease therapies)
Required skills
Global strategy and standards setting, contamination control strategy (Annex 1), aseptic processing technical excellence, aseptic process simulation (media fills), contamination event response and investigations, quality risk management (ICH Q9), regulatory intelligence and inspection readiness, new product introduction and tech transfer, innovation in microbial methods, people leadership and capability building
Preferred skills
Master's degree or PhD in microbiology, Quality Assurance or Quality Control experience, AI and advanced analytics for environmental monitoring
Technologies
Isolators, rapid microbial methods, advanced analytics, HVAC systems, sterilization technologies
Responsibilities
Define and harmonize global sterility assurance standards; lead contamination control strategy development; establish aseptic processing and cleanroom design standards; manage aseptic process simulation programs; coordinate contamination event investigations; apply quality risk management tools; act as lead technical SME for regulatory inspections; guide new product introduction and tech transfer; drive innovation in microbial detection methods; mentor and build capability in microbiology and aseptic teams
Seniority
Senior, strategic leadership with hands-on technical oversight