Head of Sterility Assurance and Contamination Control

About the role

AstraZeneca is looking for a Head of Sterility Assurance and Contamination Control to set the global standard for sterility assurance and contamination control across its worldwide network producing therapies for people with rare diseases. Reporting to the Executive Director of Technical Operations, the role owns the global strategy and harmonizes standards across Drug Substance, Drug Product and Combination Product manufacturing at internal sites and CDMOs, embedding sterility assurance within the Pharmaceutical Quality System.

Key responsibilities

• Set and own the global sterility assurance and contamination control strategy and standards, ensuring consistent application and measurable outcomes.
• Define the technical content of contamination control strategy documents, review and approve site CCS with QA, and verify effectiveness through periodic reviews.
• Establish network standards for aseptic design, cleanroom qualification, EM programs, gowning, personnel qualification, material transfer and sterilization validation, and own the global aseptic process simulation strategy.
• Coordinate contamination event responses, lead investigations and root cause analysis, define CAPA, and assess product impact for batch disposition.
• Apply ICH Q9 tools, trend EM and deviation data, define SA&CC metrics and KPIs, own SA&CC procedures in document control, and support self-inspections.
• Act as lead technical SME in inspections and audits, close observations, and contribute SA&CC content for submissions and regulatory responses.
• Embed contamination control by design in new products and facilities, and serve on the NPI/Tech Transfer steering group.
• Set standards for microbiological methods, introduce rapid microbial methods, isolators, automation and advanced analytics, and mentor site microbiology and aseptic teams.

Required profile

• Bachelor's degree in microbiology, biology or a related life science.
• 15+ years in sterility assurance, aseptic processing, contamination control or industrial microbiology in biopharma within a GMP quality or technical operations environment.
• Prior functional leadership of an SA&CC function or equivalent at comparable scale, with mentoring and team development experience.
• Deep expertise in global aseptic processing regulations, with a track record of authoring and defending CCSs and acting as SME in health authority inspections.
• Experience leading sterility failure investigations, root cause analysis, product impact assessment and CAPA effectiveness.
• Experience establishing sterility assurance standards across multiple sites and/or external partners, and leading SA&CC for facility design, qualification and start-up.
• Desirable: Master's or PhD, QA/QC or CDMO quality oversight experience, and understanding of AI and advanced analytics applied to microbial data.

Required skills

• Aseptic processing, cleanroom classification, HVAC principles, sterilization technologies, EM, APS and quality risk management.
• ICH Q9 tools (FMEA, contamination risk mapping) and GMP (deviation, CAPA, change control, data integrity).
• Microbiological methods and their validation.
• Strong influencing skills at the interface of Quality and Technical Operations.