Blackfield Associates
Head of Pathogen Safety
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Head of Pathogen Safety
We are supporting a biopharmaceutical company seeking to hire a Head of Pathogen Safety. The Head of Pathogen Safety will lead the site's pathogen safety and biosafety activities, with overall management responsibility for the GLP Test Facility.
Responsibilities
- Lead and develop the Pathogen Safety team, including objectives, training, performance and resource planning.
- Hold overall responsibility for the GLP Test Facility, ensuring studies are planned, conducted, recorded, archived and reported in line with OECD GLP and UK MHRA requirements.
- Maintain a strong culture of quality, data integrity, compliance and inspection readiness.
- Lead preparation for and support MHRA GLP inspections, including responses to observations and follow-up commitments.
- Provide senior technical expertise across pathogen safety, biosafety and non-clinical safety studies.
- Support complex pathogen safety programmes, investigations, deviations and change controls where specialist expertise is required.
- Provide technical input across the GLP/GMP interface, including product lifecycle activities, regulatory submissions and batch release.
- Work closely with Quality, Manufacturing, Regulatory and scientific teams across the wider organisation.
- Provide technical support relating to biologics and other products.
- Maintain awareness of evolving regulatory requirements and industry best practice.
- Represent the function at relevant scientific and regulatory forums.
- Manage the function's budget and ensure appropriate resources are in place.
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Essential Experience
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- Degree or higher in Virology, Biology, Biochemistry or a related scientific discipline.
- Significant experience in Pathogen Safety, Biosafety or a related field.
- Extensive experience working within a GLP-regulated Test Facility.
- Experience with Test Facility Management or equivalent senior GLP accountability.
- Strong knowledge of OECD GLP and UK MHRA GLP requirements.
- Understanding of the GLP/GMP interface.
- Experience supporting biologics.
- Experience supporting regulatory inspections, ideally MHRA GLP inspections.
- Proven people leadership experience within a scientific or technical environment.
- Strong understanding of quality systems, data integrity and regulatory compliance.
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