GXP Audit and Inspection Director

Requirements

• Education
• Bachelor's or advanced degree in life sciences, pharmacy, or related field.
• Certifications or Designations
• Potential QP or QPPV experience.
• Minimum 10 years of experience in GxP auditing and regulatory inspections.
• Proven leadership in matrix‑managing global audit programs.
• Deep understanding of international GxP regulatory requirements and quality systems.
• Experience interacting with regulatory authorities during inspections.
• Knowledge and Skills
• Strong strategic thinking and risk management skills.
• Excellent communication and stakeholder management.
• Ability to influence across functions and geographies.
• High attention to detail and analytical capability.
• Leadership and team development skills.
• What we offer in return
• Opportunities for learning & development through our varied programme.
• Collaborative, inclusive work environment.
• For more information visit www.mundipharma.com..
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• Additional Job Description:
• Primary Location:
• GB Cambridge Job Posting Date:
• 2026-01-14 Job Type:
• Permanent

Benefits

Additional Information

GxP Audit and Inspection Director Location: Cambridge Department: Quality Job type: Permanent Join us and make a difference when it matters most! At Mundipharma, we are proud of the work we do to uphold the highest standards of quality, compliance, and patient safety. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. The Team The role will strategically lead and coordinate the global GxP audit and inspection readiness program, ensuring sustained compliance with international regulatory standards across all Good Practice domains. You will drive proactive inspection preparedness, orchestrate cross‑functional audit activities, and embed a culture of continuous improvement within quality systems. This role ensures alignment of global teams on inspection strategy, robust documentation and data integrity, and operational excellence through risk‑based compliance oversight and regulatory intelligence. Role and Responsibilities Strategic Leadership Develop and execute a global GxP audit and inspection strategy aligned with company objectives and the Quality Management System. Lead cross‑functional inspection readiness programs, including mock inspections. Serve as the primary point of contact for regulatory inspections. Audit Program Management Oversee internal and external audit programs across all GxP areas, including vendor and supplier audits. Ensure audit schedules are risk‑based and cover all relevant GxP domains. Inspection Readiness Coordinate pre‑inspection activities such as training, documentation review, and facility walkthroughs. Lead inspection response teams and manage post‑inspection responses, remediation, and CAPA execution. Governance and Reporting Provide regular updates to senior leadership on audit outcomes, inspection risks, and compliance trends. Maintain metrics and dashboards to monitor audit performance and inspection readiness. Team Leadership Build and manage a high‑performing global audit team who demonstrate a growth mindset and make decisions based on the patient. Provide coaching, development, and performance management to the team. Stakeholder Engagement Collaborate effectively with Quality, Safety, Regulatory Affairs, R&D, Manufacturing and other functions to ensure proactive inspection readiness. Be an active member of the Quality Leadership Team representing audit and inspections. Represent the company in regulatory interactions and industry forums.

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