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.