Director of Pathogen Safety & GLP Compliance

Blackfield Associates; England; On-site; GBP 120,000 - 180,000; Full time

Job summary

Blackfield Associates is partnering with a biopharmaceutical company to appoint a Head of Pathogen Safety. This role leads the site's pathogen safety and biosafety activities with overall management responsibility for the GLP Test Facility.

You will lead the Pathogen Safety team, ensure studies are conducted in line with OECD GLP and UK MHRA requirements, maintain data integrity, and support regulatory inspections. A strong background in GLP facilities and regulatory submissions is essential.

Qualifications

• 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.

Responsibilities

• Lead and develop the Pathogen Safety team, including objectives, training 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.

Skills

Pathogen Safety

Biosafety

Regulatory compliance

People leadership

Quality systems

Education

Degree or higher in Virology, Biology, Biochemistry or related discipline

Job description

Blackfield Associates is partnering with a biopharmaceutical company to appoint a Head of Pathogen Safety. This role leads the site's pathogen safety and biosafety activities with overall management responsibility for the GLP Test Facility.

You will lead the Pathogen Safety team, ensure studies are conducted in line with OECD GLP and UK MHRA requirements, maintain data integrity, and support regulatory inspections. A strong background in GLP facilities and regulatory submissions is essential.