Sterility Assurance Manager

Overview: This is a senior-level sterility assurance role at a specialist pharmaceutical manufacturing site focused on sterile and aseptic production. The successful candidate will lead the sites sterility assurance strategy and be responsible for ensuring compliance with EU GMP Annex 1, supporting inspection readiness, and embedding a culture of proactive quality and contamination control. You’ll serve as the site’s ME for all matters related to contamination risk and aseptic practices, supporting production, QC, engineering, and facilities. Key Responsibilities: Develop, implement and maintain the sites Contamination Control Strategy and sterility-related quality plans. Lead and mentor the sterility assurance team, driving capability, ownership, and performance. Oversee the development of SOPs, protocols, and sterility-related documentation. Act as the lead SME for cleanroom and utility monitoring, aseptic process simulations, sterilisation methods, disinfection routines, and environmental controls. Review and interpret microbiological data and trend analyses to ensure early risk detection and mitigation. Support and lead investigations, deviations, CAPAs and risk assessments related to aseptic processes. Collaborate closely with Production, QC and Engineering to embed a site-wide sterility mindset. Ensure the site maintains a Sterility Assurance Risk Register and a forward-looking Quality Improvement Plan. Contribute to audit readiness, regulatory inspections, and continuous improvement initiatives. Support the wider QA leadership team with cross-functional quality projects. Stay up to date with regulatory developments and evolving industry best practice. Experience & Background: Significant experience in pharmaceutical QA, microbiology, or sterility assurance within a sterile/aseptic manufacturing environment. Proven understanding of GMP, with strong expertise in Annex 1 requirements. Strong knowledge of environmental and utility monitoring systems, aseptic techniques, and microbial risk assessment. Hands-on involvement with investigations, deviations, CAPAs and audit responses. Excellent communication and stakeholder management skills. Scientific degree and membership of a relevant professional body preferred. Prior leadership experience is desirable, but senior specialists ready to step up will be considered. Additional Details: Full-time, site-based position. The company offers a supportive culture and is focused on continuous improvement across QA and manufacturing.