R&D QA Lead Auditor/Advisor - GCP
Location: Cambridge, Hybrid
Department: Global Quality Systems
Job type: 12-month initial contract - potential to be extended
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
We are seeking a highly motivated and experienced R&D Quality Assurance (QA) Lead Auditor/ Advisor to join our Global Quality Systems team at Mundipharma, reporting to the Director of Global Quality Systems. You will play a key role in developing and leading R&D audit schedules, managing third-party audits, and providing expert QA guidance across Mundipharma, ensuring adherence to global standards and best practices.
The ideal candidate will have a proven background in GCP with experience in supporting CAPA's, audit findings and deviations with the ability to host inspections and being involved in remediations.
Role and Responsibilities
Plan and execute GxP audits (internal, vendors, partners, investigational sites) and manage the R&D audit schedule.
Oversee contract auditor activities, including scheduling, coordination, and documentation.
Generate audit reports, manage CAPAs, and ensure timely resolution of compliance issues.
Maintain audit management systems in alignment with GxP, regulatory requirements, and company policies.
Monitor audit metrics to identify risks, drive continuous improvement, and escalate issues as needed.
Support regulatory inspections, including preparation, coordination, and response management.
Provide GxP compliance advice and support to internal teams and during business meetings.
Ensure third-party compliance with Quality Agreements and follow up on quality, safety, and efficacy concerns.
Develop and maintain SOPs and support GxP training and documentation activities.
Collaborate cross-functionally to ensure regulatory compliance, support improvement initiatives, and align with corporate strategy.
What you’ll bring
Proven experience in an auditing or QA role within the Pharmaceutical Industry in a GCP discipline with experience in supporting CAPA's, audit findings and deviations
Scientific degree in Pharmacy, Chemistry, Biology, Engineering, or relevant experience with auditing certification.
Extensive experience in auditing or QA within the Pharmaceutical Industry (GCP/GVP).
Extensive knowledge of Global GxP guidelines (UK, EU, FDA, PIC/S, WHO, ICH) and regulatory legislation.
Strong understanding of EU CTD format, drug development process, and contracts with CROs & vendors for audits and evaluations.
Expertise in auditing techniques, deviation reporting, root cause analysis, and CAPA management.
Ability to critique technical information, assess compliance risks, and apply GxP regulations.
Effective communicator across all levels, ensuring successful independent QA audits and stakeholder management.
Strong organizational skills, ability to manage workload efficiently, and work individually or in cross-functional teams.
Proficient in technical report writing, audit documentation, and compliance reporting.
Skilled in Microsoft Office (Word, Excel, PowerPoint, Outlook) and other relevant project tools.
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. For more information visit www.mundipharma.com.
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Additional Job Description:
Primary Location:
GB CambridgeJob Posting Date:
2025-03-21Job Type:
Fixed Term Contract (Fixed Term)
