Head, Pv And Regulatory Qa

CSL Seqirus

10+ years pharmaceutical qa experience
Gvp module iv audit strategy expertise
End-to-end pharmacovigilance process knowledge
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 manage all health authority inspections.
  • CSL Seqirus offers a culture of inclusion and belonging where innovation is fueled by celebrating differences and fostering empathy.

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 audit strategy expertise
  • End-to-end pharmacovigilance process knowledge
  • Deviation and CAPA management proficiency
  • Global cross-functional team leadership

Nice-to-have

  • Executive presence for stakeholder influence
  • Deep knowledge of GCP GDP GCLP regulations
  • Experience with PV IT system oversight
  • Strategic budget development skills
  • Continuous improvement initiative mindset

Key Requirements

  • Undergraduate degree in Scientific or Life Sciences
  • Advanced degree preferred
  • Senior leadership capacity proven track record
  • International pharmacovigilance guidelines mastery

Work Rights

Not specified

Tailored Resume

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