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 bodiesConduct treatment center audits where requiredEngage with Audit Management, Vendor Management, and Apheresis/Infusion Operations on-site qualificationsEstablish and maintain Quality AgreementsCollaborate with business areas on site selectionProvide QA support for change controls, investigations, CAPAs, and effectiveness checksIdentify risks and communicate gaps for processes and systemsCoordinate preparation activities with Subject Matter ExpertsMaintain real-time inspection readinessDevelop and mature tools to improve execution efficiencySupport inspection-related history maintenance for readiness purposesIdentify areas for improvement and participate in process improvement initiativesProvide additional support to processes, systems, and procedures to ensure continuous quality improvementSupport Quality Systems with additional activities as neededAuthorise or revise Standard Operating Procedures and associated formsKnowledge and Skills

Strong apheresis and/or cellular therapy quality or operations backgroundProject management skillsOperational QA experience with preferred on inspection support and quality systemsUnderstanding of GMP/GDP/GTP and applicable guidelinesAbility to collaborate with cross-functional teamsExcellent technical writing, presentation, and communication skillsExperience conducting investigations, root cause analysis, and identifying CAPAsEducation and Experience

Bachelor’s or Master’s degree requiredBackground in Quality Assurance supporting apheresis, transplant, or cell-therapy lab in biotech/pharma or healthcare settingEmployment type

ContractJob function

Quality AssuranceIndustries

Biotechnology; Pharmaceutical Manufacturing

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