Head, Pv And Regulatory Qa

CSL Behring

10+ years pharmaceutical qa experience
Deep knowledge of gvp/gcp regulations
End-to-end pharmacovigilance process mastery
The role leads the global quality and compliance function ensuring end-to-end PV processes remain compliant with international regulations

Job Summary

  • The role leads the global quality and compliance function ensuring end-to-end PV processes remain compliant with international regulations.
  • Candidates must possess a proven track record in senior leadership with deep technical knowledge of GVP and GCP guidelines.
  • The position involves directing both strategic evolution and operational delivery including audit strategies, inspection responses, and system health monitoring.

Matching Summary

The role leads the global quality and compliance function ensuring end-to-end PV processes remain compliant with international regulations.

Skills & Requirements

Must-have

  • 10+ years pharmaceutical QA experience
  • Deep knowledge of GVP/GCP regulations
  • End-to-end pharmacovigilance process mastery
  • Risk-based audit strategy development
  • Inspection readiness and regulatory management
  • Deviation and CAPA workflow oversight

Nice-to-have

  • Executive presence for global influence
  • Cross-functional leadership in R&D
  • Strategic vision alignment with business goals
  • Experience with third-party vendor management
  • Continuous improvement initiative implementation

Key Requirements

  • Undergraduate degree in Scientific or Life Sciences discipline
  • Advanced degree preferred
  • 10+ years industry tenure specifically within Quality Assurance
  • Senior leadership capacity experience required

Work Rights

Not specified

Tailored Resume

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