R&D QA Manager - GVP

** R&D QA Manager - GVP
*****
* Location:

**** Cambridge, Flexible Hybrid
**** Department:
**** Quality Assurance
**** Job type:
**** Full Time
**** Join us and make a difference when it matters most!
**** 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 Team
**** The R&D QA Manager will join the Quality Assurance team at Mundipharma and take a lead role in our Pharmacovigilance (PV) quality  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.
**** Role and 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
**** What you’ll bring
***** 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)
* 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
* 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
**** What we offer in return
***** Flexible benefits package
* Opportunities for learning & development through our varied programme
* Collaborative, inclusive work environment
**** Diversity and inclusion
**** Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.

**** About Mundipharma
**** Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.  Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do.

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** Additional

Job Description:

**** Primary

Location:

** GB Cambridge
** Job Posting Date:
**** Job Type:
** Permanent
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