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Site head of quality (gmp)

AssureBio
Head of quality
Posted: 17 November
Offer description

Overview AssureBio is supporting a leading pharmaceutical manufacturer in the appointment of a Site Head of Quality to oversee all GMP Quality activities at a key UK manufacturing facility in Cambridgeshire. This pivotal leadership position will provide strategic and operational oversight of site Quality, ensuring compliance with GMP and global regulatory expectations. The successful candidate will act as the senior Quality representative on the Site Leadership Team, partnering closely with Operations and Quality functions to ensure inspection readiness, data integrity, and the consistent delivery of compliant, high-quality medicines to patients. Key Responsibilities Quality Leadership: Represent the Quality function on the Site Leadership Team, providing strategic direction and ensuring compliance with GMP and corporate Quality objectives. Compliance & Inspection Readiness: Maintain continuous inspection readiness. Lead site preparation and response to internal and external audits and regulatory inspections (e.g., MHRA, EMA, FDA). Quality Systems Management: Oversee site-specific Quality Systems including deviation management, CAPA, change control, documentation, and data integrity. Cross-Functional Collaboration: Partner with QPs, QA, QC, Validation, and Manufacturing to support product release and drive continuous improvement initiatives. Team Development: Lead and develop teams across Quality Control, Analytical Services, Stability Testing, and Quality Systems to foster a high-performance, patient-focused culture. Experience & Qualifications 8 years of experience in pharmaceutical manufacturing and Quality leadership roles. Strong working knowledge of GMP, GDP, and global regulatory frameworks. Demonstrated success in managing Health Authority inspections and Quality teams within complex operations. Degree in Life Sciences, Pharmacy, Chemistry, or a related field (advanced qualifications or QP status desirable). Proven ability to lead cross-functional collaboration, influence stakeholders, and embed Quality culture at all levels.

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