GxP Audit and Inspection Director
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
* 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.
* 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, R&D, Manufacturing and other functions to ensure proactive inspection readiness.
* Act as active member of the Quality Leadership Team and represent the company in regulatory interactions and industry forums.
Qualifications
* Education: Bachelor’s or advanced degree in life sciences, pharmacy, or related field.
* Certifications: 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.
* Ability to influence across functions and geographies.
* High attention to detail and analytical capability.
* Leadership and team development skills.
Benefits
Opportunities for learning & development through our varied programme. Collaborative, inclusive work environment. Diversity and inclusion.
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