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Lead Quality Assurance Consultant - United Kingdom & Ireland
Blackfield are working with a leading biopharmaceutical organisation based in Stevenage in the search for a Senior Specialist, Supplier Management on a hybrid basis.
The Senior Specialist, QA Supplier Management will be a pivotal member of the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for both clinical and commercial use across the UK, EU, and US. This position will ensure compliance with Good Manufacturing Practice (GMP) and uphold the Pharmaceutical Quality System, with a particular focus on supplier qualification, auditing, and ongoing vendor oversight. Acting as a Subject Matter Expert in supplier management, quality documentation, and inspection readiness, the role will also contribute to continuous improvements across all quality systems and processes.
Key Responsibilities:
* Manage the qualification, auditing, and continued oversight of third-party suppliers, ensuring that only approved materials and services are utilised in production and quality control.
* Review and approve GxP documentation, including Batch Manufacturing Records, SOPs, validation protocols, and quality reports, escalating issues when necessary.
* Lead internal audits, coordinate inspection readiness activities, and act as SME during regulatory inspections.
* Deliver training, mentoring, and operational leadership to the QA team, deputising for the QA Manager and supporting manufacturing authorisations and licence variations.
The ideal candidate will demonstrate excellent communication skills, a collaborative approach, and a proven ability to lead projects in a regulated environment. They will possess the confidence to influence stakeholders, build strong cross-functional relationships, and drive quality improvements within complex operations.
If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Biotechnology Research and Pharmaceutical Manufacturing
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