Head, Pv And Regulatory Qa

Century Center

10+ years pharmaceutical qa experience
Gvp module iv regulatory knowledge
Global audit strategy development
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.
  • You will own the long-term risk-based audit strategy aligned with GVP Module IV and lead preparation for health authority inspections.
  • CSL Seqirus offers a culture of inclusion and belonging while providing state-of-the-art production facilities across the U.S., U.K., and Australia.

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
  • GVP Module IV regulatory knowledge
  • Global audit strategy development
  • CAPA and deviation management expertise
  • Health authority inspection leadership

Nice-to-have

  • Executive presence for cross-functional influence
  • Experience with third-party vendor management
  • Knowledge of GCP, GDP, and GCLP standards
  • Strong strategic vision for R&D Quality
  • Ability to manage complex budgets and resources

Key Requirements

  • Undergraduate degree in Life Sciences (Advanced preferred)
  • 10+ years industry tenure in Quality Assurance
  • Proven senior leadership track record
  • Deep knowledge of GVP/GCP regulations

Work Rights

Not specified

Tailored Resume

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