This newly created, site-based role at Pirbright is responsible for overseeing all production compliance activities across the manufacturing facility. The position ensures timely, cost-effective production of FMD and BTV antigens and finished products, fully aligned with EU, UK, and company GMP, biosafety, and HSE regulations.
TASKS & RESPONSIBILITIES
Production Compliance
Lead and manage the Production GMP Compliance team
Oversee departmental deviations, CAPAs, change controls, SOPs, MBRs, and training, ensuring timely closure aligned with KPIs
Conduct and lead investigations with high technical competence
Develop and manage Production Compliance KPIs
Maintain training records, OJT programs, and data integrity standards
Operational Management
Ensure departmental efficiency and regulatory compliance
Support and deputise for the Head of Production
Continuously improve compliance processes, equipment, and training
Collaborate with senior colleagues to resolve inefficiencies and implement improvements
Collect and act on KPI data to reduce product wastage
Strengthen relationships with internal and external stakeholders, especially Quality Assurance and Boehringer's network colleagues
Area Management
Plan and implement process improvements via change control
Manage team schedules and provide cover during absences
Coach and train staff, promoting cross-area collaboration
Oversee training budgets and contribute to annual budget planning
Participate in the production call-out rota and ensure batch close-out within 12 weeks
Continuous Improvement
Lead and participate in daily Tier Meetings
Drive key improvement projects and support cross-functional initiatives
Biosafety & EHS
Ensure adherence to biosafety protocols and communicate effectively
Report and investigate EHS incidents, collaborating with EHS teams
Conduct and document risk assessments
Complete required Health & Safety training
Finance & Systems
Monitor training cost centre budgets and report discrepancies
Approve invoices and manage stock movements in SAP/GBS
Plan stock usage and raise orders via WeBuy
GMP & Audits
Lead production readiness for internal and external audits
Act as SME during audit front-room activities
Manage change controls, deviations, CAPAs, and OOS reports
Approve and enter data in LIMS
REQUIREMENTS
Degree in a biological discipline preferred; relevant experience considered
Strong time management, organisational, and leadership skills
In-depth knowledge of HSE, biosafety, GMP, and operational excellence
Proven autonomy and teamwork capabilities
Experience in regulated environments desirable
Innovative mindset with strong communication skills
Proficient in Microsoft Office
Demonstrates Accountability, Agility & Intrapreneurship (AAI) behaviours
WHY THIS IS A GREAT PLACE TO WORK
Boehringer Ingelheim has been recognised as a Top Employer in the UK. Being certified as a Top Employer confirms our dedication to a better world of work, delivered through excellent HR policies and people practices. To learn more visit: https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work
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