Head of Pathogen Safety
Blackfield Associates · Hertfordshire, England, United Kingdom
Apply & track with Apply EdgeWe 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.ResponsibiltiesLead 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.Essential ExperienceDegree 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.