Audit Manager

Elvium

Cambridge, GB
Fully remote
Gmdp audit scheduling and execution
Risk-based audit management
Audit process ownership
Develop and lead the Rx Central Quality Auditor community to manage GMDP audits of CMOs, third parties, and internal manufacturing organizations

Job Summary

  • Develop and lead the Rx Central Quality Auditor community to manage GMDP audits of CMOs, third parties, and internal manufacturing organizations.
  • Establish and maintain audit systems, standards, and metrics to enable effective, risk-based auditing in compliance with legislation and guidelines.
  • Mundipharma offers an inclusive and collaborative culture with a strong focus on safety, training, career development, and competitive salary.

Matching Summary

Develop and lead the Rx Central Quality Auditor community to manage GMDP audits of CMOs, third parties, and internal manufacturing organizations.

Skills & Requirements

Must-have

  • GMDP audit scheduling and execution
  • Risk-based audit management
  • Audit process ownership
  • Cross-functional audit coordination
  • Audit metrics and reporting
  • Quality agreements and CAPA management

Nice-to-have

  • Global collaboration and alignment
  • Talent identification and development
  • Continuous professional development
  • Inspection readiness support
  • Ethical standards and auditor independence

Key Requirements

  • Scientific degree in Pharmacy, Chemistry, Biology or similar
  • Lead Auditor certification or equivalent
  • Experience in GMDP/GxP audit management

Work Rights

Not specified

Tailored Resume

Cover Letter