GXP Audit and Inspection Director
UK Visa Sponsorship Analytics
Occupation Type
Functional managers and directors not elsewhere classified.
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£74,700
(£38.31 per hour)
Occupation rate applies
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Description
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
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.
- 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.
- 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.
- 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.
- 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
Education
- 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.
Education
- Bachelor’s or advanced degree in life sciences, pharmacy, or related field.
- 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.
- Strong strategic thinking and risk management skills.
- Excellent communication and stakeholder management.
- Opportunities for learning & development through our varied programme.
- Collaborative, inclusive work environment.
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 Cambridge
Job Posting Date:
2026-01-14
Job Type:
Permanent
GB Cambridge
Job Posting Date:
2026-01-14
Job Type:
Permanent