Overview
Vertex Pharmaceuticals is seeking a Quality Manager, ATC Operational Quality for a contract role (Inside IR35) based in London, Paddington. The role supports activation of commercial gene therapy Authorized Treatment Centers, performing quality risk assessments, assisting with quality agreements, and providing operational QA support for site selection and activation of apheresis and cell-therapy laboratories. The Quality Manager will work with QA Audit, Apheresis, Infusion Operations, and other stakeholders to ensure readiness, transparency, and continuous quality improvement in delivering life-saving cell and gene therapies.
Key Duties and Responsibilities
* Work with the Audit and Inspection quality function to establish the audit strategy for auditing and performance oversight to evaluate treatment centers for compliance with applicable regulatory, licensing, and accrediting bodies
* Conduct treatment center audits where required
* Engage with Audit Management, Vendor Management, and Apheresis/Infusion Operations on-site qualifications
* Establish and maintain Quality Agreements
* Collaborate with business areas on site selection
* Provide QA support for change controls, investigations, CAPAs, and effectiveness checks
* Identify risks and communicate gaps for processes and systems
* Coordinate preparation activities with Subject Matter Experts
* Maintain real-time inspection readiness
* Develop and mature tools to improve execution efficiency
* Support inspection-related history maintenance for readiness purposes
* Identify areas for improvement and participate in process improvement initiatives
* Provide additional support to processes, systems, and procedures to ensure continuous quality improvement
* Support Quality Systems with additional activities as needed
* Authorise or revise Standard Operating Procedures and associated forms
Knowledge and Skills
* Strong apheresis and/or cellular therapy quality or operations background
* Project management skills
* Operational QA experience with preferred on inspection support and quality systems
* Understanding of GMP/GDP/GTP and applicable guidelines
* Ability to collaborate with cross-functional teams
* Excellent technical writing, presentation, and communication skills
* Experience conducting investigations, root cause analysis, and identifying CAPAs
Education and Experience
* Bachelor’s or Master’s degree required
* Background in Quality Assurance supporting apheresis, transplant, or cell-therapy lab in biotech/pharma or healthcare setting
Employment type
* Contract
Job function
* Quality Assurance
Industries
* Biotechnology; Pharmaceutical Manufacturing
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