Gxp Audit And Inspection Director

Mundipharma

Cambridge, United Kingdom
10+ years gxp auditing experience
Global inspection readiness strategy
Regulatory authority interaction
The role strategically leads and coordinates the global GxP audit and inspection readiness program to ensure sustained compliance with international regulatory standards

Job Summary

  • The role strategically leads and coordinates the global GxP audit and inspection readiness program to ensure sustained compliance with international regulatory standards.
  • You will serve as the primary point of contact for regulatory inspections, leading response teams and managing post-inspection remediation and CAPA execution.
  • Mundipharma offers a collaborative, inclusive work environment where diversity is prioritized and employees are encouraged to bring their authentic selves to work.

Matching Summary

The role strategically leads and coordinates the global GxP audit and inspection readiness program to ensure sustained compliance with international regulatory standards.

Skills & Requirements

Must-have

  • 10+ years GxP auditing experience
  • Global inspection readiness strategy
  • Regulatory authority interaction
  • Risk-based audit program management
  • Cross-functional team leadership

Nice-to-have

  • Growth mindset culture
  • Patient-centric decision making
  • Inclusive work environment
  • Continuous improvement mindset
  • Strategic thinking skills

Key Requirements

  • Bachelor's or advanced degree in life sciences
  • Minimum 10 years GxP auditing experience
  • QP or QPPV certification preferred
  • Matrix management of global audit programs
  • Experience with regulatory authority interactions

Work Rights

Not specified

Tailored Resume

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