Allerton Bishop is partnering with a leading pharmaceutical manufacturing company to appoint a Senior Manager of Sterility Assurance. Based in the UK, this is a senior leadership position within a manufacturing facility focused on sterile drug product, with responsibility for leading a team across Microbiology and Sterility Assurance.
This is a pivotal role within a GMP sterile pharmaceutical manufacturing facility, where you will provide strategic and operational leadership across sterility assurance, microbiology and contamination control, ensuring the site maintains the highest standards of microbial control and sterility assurance across its manufacturing operations.
Key Responsibilities
- Lead, mentor and develop a team across Microbiology and Sterility Assurance, building a high-performing culture focused on scientific excellence and patient safety.
- Provide strategic leadership for the site's sterility assurance programme, ensuring robust contamination control and microbial control strategies are embedded across sterile manufacturing operations.
- Ensure all sterility assurance and microbiology activities comply with GMP, regulatory, safety and quality requirements.
- Partner closely with Manufacturing, Quality Assurance, Engineering and Technical Operations to maintain and continuously improve the site's contamination control strategy.
- Provide expert oversight of environmental monitoring, aseptic process simulations, microbiological testing, cleanroom controls and sterility assurance activities.
- Lead and support investigations relating to contamination events, environmental monitoring excursions, sterility failures and other microbiological or aseptic process risks.
- Act as a key technical leader for regulatory inspections, audits and quality initiatives, providing expertise across sterility assurance and microbiology.
- Drive continuous improvement across sterility assurance systems, processes and ways of working, ensuring the site remains aligned with evolving regulatory expectations and industry best practice.
- Support the introduction, transfer and ongoing manufacture of sterile drug products, ensuring appropriate sterility assurance considerations are incorporated throughout the product lifecycle.
Your Background
- Degree in Microbiology, Life Sciences, Pharmaceutical Sciences or a related scientific discipline.
- Extensive experience within sterile pharmaceutical manufacturing, with significant expertise in sterility assurance and microbiology.
- Proven experience leading microbiology and/or sterility assurance teams within a GMP manufacturing environment.
- Strong technical understanding of contamination control, environmental monitoring, aseptic processing, cleanroom microbiology and sterility assurance principles.
- Experience leading investigations, risk assessments and remediation activities associated with microbiological and sterility assurance issues.
- Strong understanding of current GMP and regulatory expectations relating to sterile manufacturing.
- Demonstrated ability to influence cross-functional teams and drive a strong culture of contamination control and quality across a manufacturing site.
- Experience supporting regulatory inspections and operating at a senior site leadership level would be highly advantageous.
Head of Sterility Assurance | Sterility Assurance | Microbiology | Contamination Control | Aseptic Manufacturing | Sterile Drug Product | GMP | Environmental Monitoring | Pharmaceutical Manufacturing | Sterility Assurance Manager | Head of Microbiology | Quality Leadership