R&D QA Manager - GVP

Mundipharma

2d•Hybrid

About The Position

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. The R&D QA Manager will join the Quality Assurance team at Mundipharma and take a lead role in our Pharmacovigilance (PV) quality oversight. In this critical position, you will act as a guardian of patient safety and regulatory compliance. You will play a pivotal role in vendor management, the integrity of the Pharmacovigilance System Master File (PSMF), and supporting the wider business through high-level regulatory inspections.

Requirements

Scientific degree in Pharmacy, Chemistry, Biology, Engineering or similar, or aligned working experience
Certification in Quality Systems Management and/or auditing or similar
Extensive practical experience in QA roles within the Pharmaceutical and/or Medical Devices Industry
Expert GVP Knowledge: Proven experience in Quality Assurance with a specific focus on Good Pharmacovigilance Practice (GVP)
In-depth knowledge of auditing techniques and valid, concise and clear reporting style and how to utilise these effectively.
Knowledge of deviation reporting, root cause analysis and CAPA
Autonomy: The ability to work independently, manage your own workload, and make risk-based quality decisions with confidence

Nice To Haves

Working knowledge of Good Clinical Practice (GCP) is preferred and would be a strong advantage
A proven track record of supporting PV teams during interactions with regulators (e.g., MHRA, EMA, FDA) to a very high level

Responsibilities

Audit planning and maintenance of the R&D Audit Schedule
Lead the oversight of third-party vendors and service providers from a quality perspective
Take ownership of specialty quality tasks, specifically regarding the Pharmacovigilance System Master File (PSMF)
Conduct R&D audit activities, including acting as lead or co-auditor
Support GxP Regulatory Inspection activities
Act as the primary Subject Matter Expert (SME) for GVP/GxP compliance, providing technical advice to project teams and interpreting new regulations to ensure proactive business readiness.
R&D CAPA management from regulatory inspections, vendor and internal audit reports
Quality review and approve change controls, deviations and CAPAs from deviations raised by Global Scientific Affairs
Generation, analysis and presentation of R&D quality metrics
Provide QA support on GxP compliance and related risks to the business
Provision of QA support for due diligence of new products to be brought into the company portfolio