OMQ-P2-11 QA Lead Auditor/Advisor Location: Cambridge Department: Global Quality Systems 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: 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 Research Limited (MRL). Reporting to the Director of Global Quality Systems. The ideal candidate will have a proven track record in R&D quality assurance, GxP auditing, and regulatory compliance within pharmaceutical or life sciences organizations. They 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. Role and Responsibilities: Audit Planning, Execution & Compliance Develop and maintain the R&D Audit Schedule, ensuring audits align with stakeholder needs. Conduct GxP audits of vendors, marketing partners, and investigational sites. Perform internal audits to assess compliance with SOPs and GxP regulations. Oversee contract auditor activities, including scheduling and document coordination. Generate audit reports, track CAPAs, and ensure timely issue resolution. Support Deviation Investigations and CAPA documentation management. Audit Governance, Compliance Management & Continuous Improvement Maintain R&D audit management systems, ensuring compliance with GxP, regulatory standards, and Mundipharma policies. Ensure effective processes, resources, and training are in place for audit execution. Implement audit metrics to identify risks, drive improvements, and escalate issues proactively. Drive continuous improvement initiatives to enhance compliance and efficiency. Stay updated on industry regulations and recommend strategies for upcoming requirements. Support the development and delivery of GxP training to business teams. GxP Audits, Third-Party Compliance & Regulatory Inspection Support Manage the R&D audit schedule and lead GxP audits of IACs, CMOs, CROs, and third parties. Ensure audits align with Mundipharma standards and assess compliance with Quality Agreements. Identify and track CAPAs to closure, ensuring timely resolution of findings. Oversee escalation and follow-up on product quality, safety, and efficacy issues. Support marketing partner audits and regulatory GxP inspections, including preparation and coordination. Facilitate responses to regulatory inspections, ensuring CAPAs are effectively managed. Collaborate with third-party organizations and internal teams to align on quality risk management and audit scope. GxP Compliance Advisory & Regulatory Support Provide expert advice on GxP issues and conduct necessary research for informed decision-making. Offer ongoing compliance guidance in business meetings to ensure GxP regulations are followed. Support MRL and Scientific Affairs in maintaining SOPs and documents to ensure GxP compliance. Regulatory Compliance, Quality Management & Cross-Functional Collaboration Ensure compliance with statutory regulations, quality management, health & safety, and business ethics. Develop, revise, and maintain Standard Operating Procedures (SOPs) as needed. Support GxP compliance and contribute to relevant projects and improvement initiatives. Collaborate with IACs and third parties to ensure adherence to regulatory requirements. Continuously align with Mundipharma’s strategy and drive operational improvements. Perform additional tasks as required to support business and compliance objectives. What you’ll bring 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. 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. Additional Job Description: Primary Location: GB Cambridge Job Posting Date: 2025-03-21 Job Type: Fixed Term Contract (Fixed Term)