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Lead Biosafety Excellence
Lead biosafety excellence in a high-impact, Elstree-based role under the Global Pathogen Safety leadership with global influence. As Head of Biosafety, you will provide strategic and operational leadership to ensure the successful delivery of Pathogen Safety and GLP Test Facility activities aligned with Global Pathogen Safety strategy and global portfolio objectives.
This role is central to maintaining regulatory compliance, driving high standards across non-clinical safety studies, and supporting both lifecycle and new development programmes. Acting as the key interface between GLP and GMP activities, you will oversee Elstree GLP Test Facility, ensuring full compliance with OECD and MHRA standards and leading inspection readiness.
You will build and lead a high-performing team, manage budgets, and contribute to organisational strategy, playing a critical role in protecting patients through pathogen safety within a leading plasma-derived products business.
What You'll Do
- Lead and manage the Biosafety team at the Elstree site, providing direction to senior scientists and overseeing a team of approximately 9
- Oversee all GLP Test Facility activities, ensuring alignment with global strategy and full regulatory compliance
- Ensure all non-clinical safety studies are planned, conducted, and reported in line with OECD GLP and MHRA requirements
- Act as the primary representative for GLP inspections, ensuring inspection readiness and leading responses to observations
- Maintain accountability for data integrity, quality systems, and regulatory compliance across Biosafety operations
- Lead, develop, and motivate a high-performing team, managing both direct and matrix resources
- Provide technical leadership and troubleshooting expertise across pathogen safety and GLP-regulated activities
- Partner with internal and external stakeholders, offering expert advice and ensuring effective communication across functions
- Manage Biosafety budgets and ensure resources are aligned with business and compliance needs
- Act as the site lead for Biosafety covering health and safety, training, standards, staffing, and KPI performance
- Support production investigations, change controls, and quality reporting to enable timely batch release
- Lead regulatory contributions, including filings and responses to health authority questions
- Maintain awareness of industry best practices in pathogen safety and apply continuous improvement
- Collaborate across the wider scientific community through knowledge sharing, publications, and conferences
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Qualifications
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- Degree (BSc, MSc, or PhD) in Virology, Biochemistry, Biology, or a related field
- Proven senior-level experience within a GLP-regulated test facility, including Test Facility Management responsibility
- Strong expertise in GLP regulations (MHRA, EU, US) and their application within biologics
- Demonstrated experience supporting or leading regulatory inspections (e.g. MHRA or other health authorities)
- In-depth knowledge of pathogen safety, ideally within plasma-derived products or biopharmaceuticals
- Experience within biopharmaceuticals, plasma-derived products, or relevant CRO environments conducting GLP pathogen safety studies
- Proven ability to lead complex programmes and cross-functional, multi-site teams
- Strong leadership, communication, and influencing skills, with the ability to manage complex situations
- Experience in budget management and resource planning
- Ability to work in a hybrid model (predominantly site-based) and travel internationally as required
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