GVP QA Manager
15 days ago
Liverpool
AssureBio is supporting a globally established pharmaceutical organisation in the appointment of a GVP QA Manager to strengthen its R&D Quality Assurance function. This is a high-impact role focused on pharmacovigilance quality oversight, vendor governance and regulatory inspection readiness within a global environment. You will operate as a key Quality Subject Matter Expert, ensuring robust compliance, patient safety and proactive regulatory readiness across pharmacovigilance and wider GxP activities. The position offers strong cross-functional exposure, working closely with senior stakeholders, global partners and regulatory bodies. Key Responsibilities GVP & R&D Quality Oversight • Provide leadership across pharmacovigilance QA activities within R&D and Scientific functions, • Act as SME for GVP/GxP compliance and provide expert regulatory interpretation, • Maintain oversight of Pharmacovigilance System Master File (PSMF) integrity, • Support quality due diligence for new product opportunities Audit & Vendor Management • Develop and maintain the R&D audit schedule, • Lead internal, vendor and third-party audits (acting as Lead or Co-Auditor), • Oversee quality performance of PV vendors and service providers, • Ensure effective audit closure and CAPA tracking Inspection Readiness & Compliance • Support regulatory inspection preparation and hosting (MHRA, EMA, FDA and global authorities), • Lead CAPA management arising from inspections and audits, • Provide risk-based QA advice to cross-functional teams, • Review and approve deviations, change controls and quality events Quality Systems & Continuous Improvement • Generate and present R&D quality metrics to senior stakeholders, • Deliver GxP training and guidance across the organisation, • Maintain awareness of evolving regulatory expectations and ensure business readiness, • Support continuous improvement of quality systems and processes This role is central to ensuring high standards of pharmacovigilance compliance, vendor oversight and inspection readiness across a complex global environment. Experience & Qualifications Essential • Scientific degree (Pharmacy, Chemistry, Biology, Engineering or related) or equivalent experience, • Significant QA experience within pharmaceutical and/or medical device environments, • Strong expertise in Good Pharmacovigilance Practice (GVP), • Proven experience supporting regulatory inspections and PV teams, • Experience in auditing, CAPA management and quality systems oversight, • Ability to operate autonomously and make risk-based quality decisions Desirable • Certification in auditing or Quality Systems Management, • Working knowledge of Good Clinical Practice (GCP), • Experience managing PV vendors and service providers, • Strong stakeholder engagement and influencing skills Candidates must demonstrate the ability to operate independently, provide strategic quality input and maintain strong regulatory compliance across global PV operations.