Mundipharma
GXP Audit and Inspection Director
GB Cambridge · Director
Sponsorship not specifiedDetected 30 days ago
AuditingPerformance ManagementFDA RegulatoryLeadershipCommunicationMentoringInternal AuditGxPRegulatory Affairs
About the role
- 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.
- 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.
- Certifications or Designations - Potential QP or QPPV experience.
Requirements
- Education
- Bachelor's or advanced degree in life sciences, pharmacy, or related field.
- Certifications or Designations
- Potential QP or QPPV experience.
- 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
Skills
- Strong strategic thinking and risk management skills.
Benefits
- We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
Company info
- 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.
- 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.
Equal opportunity
- 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.
Apply directly at Mundipharma →Create a free account for alerts like thisView Mundipharma immigration profile
This listing is sourced directly from Mundipharma's careers page and normalized into a canonical job model.