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- Tasks: Lead quality assurance in pharmacovigilance and ensure patient safety.
- Company: Join Mundipharma, a global healthcare innovator dedicated to patient-centric solutions.
- Benefits: Flexible benefits, learning opportunities, and a collaborative work environment.
- Why this job: Make a real impact on patient safety and regulatory compliance.
- Qualifications: Scientific degree or relevant experience in QA within pharmaceuticals.
- Other info: Diversity and inclusion are at the heart of our culture.
The predicted salary is between 36000 - 60000 £ per year.
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 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.
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.
Join our talent pool if you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.
R&D QA Manager - GVP in Cambridge employer: Mundipharma
Contact Detail:
Mundipharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R&D QA Manager - GVP in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Mundipharma. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by diving deep into GVP and GxP compliance topics. Show us you know your stuff and can talk confidently about how you’d handle real-world scenarios in quality assurance.
✨Tip Number 3
Don’t just wait for job openings; be proactive! Keep an eye on our website and apply directly. It shows initiative and helps you stand out from the crowd.
✨Tip Number 4
Follow up after interviews with a thank-you note. It’s a simple gesture that keeps you fresh in our minds and shows your enthusiasm for the role!
We think you need these skills to ace R&D QA Manager - GVP in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the R&D QA Manager role. Highlight your experience in quality assurance, especially in GVP and auditing. We want to see how your background aligns with what we do at Mundipharma!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about patient safety and regulatory compliance. Let us know how your skills can make a difference in our team.
Showcase Relevant Experience: When filling out your application, be sure to showcase any relevant experience you have with regulatory inspections or vendor management. We love seeing candidates who understand the ins and outs of the industry!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Mundipharma
✨Know Your Stuff
Make sure you brush up on your knowledge of Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP). Be ready to discuss how your experience aligns with the role, especially in terms of regulatory compliance and quality assurance.
✨Showcase Your Autonomy
Prepare examples that demonstrate your ability to work independently and make risk-based quality decisions. Think of situations where you successfully managed your workload and contributed to quality oversight without needing constant supervision.
✨Vendor Management Insights
Since vendor management is a key part of the role, come prepared with insights or experiences related to overseeing third-party vendors. Discuss any challenges you've faced and how you ensured quality compliance in those situations.
✨Be Ready for Technical Questions
Expect technical questions about auditing techniques and CAPA management. Brush up on your knowledge of deviation reporting and root cause analysis, and be ready to explain how you've applied these in past roles.
