At a Glance
- Tasks: Lead global GxP audit strategies and ensure compliance with quality standards.
- Company: Mundipharma, a leader in quality and patient safety.
- Benefits: Permanent position with competitive salary and career development opportunities.
- Other info: Join a dynamic team dedicated to excellence in compliance and quality.
- Why this job: Make a significant impact on patient safety and quality in the healthcare sector.
- Qualifications: Experience in GxP audits and strong leadership skills required.
The predicted salary is between 80000 - 100000 £ per year.
Location: Cambridge
Department: Quality
Job type: Permanent
At Mundipharma, we are proud of the work we do to uphold the highest standards of quality, compliance, and patient safety.
Responsibilities
- 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.
- 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, including coaching, development, and performance management.
- Collaborate effectively with Quality, Safety, Regulatory Affairs.
GXP Audit and Inspection Director employer: Mundipharma International Technical Operations
At Mundipharma, we foster a culture of excellence and integrity, making us an outstanding employer for the GxP Audit and Inspection Director role in Cambridge. Our commitment to quality and patient safety is matched by our dedication to employee growth, offering robust training programmes and career advancement opportunities within a collaborative environment. Join us to be part of a dynamic team that values innovation and strives for continuous improvement in the healthcare sector.
Contact Details:
Mundipharma International Technical Operations Recruitment Team
