Head, Pv And Regulatory Qa

CSL SEQIRUS

Not specified (assumed to be flexible or hybrid based on industry norms).
10+ years pharmaceutical qa experience
Gvp module iv regulatory knowledge
End-to-end pharmacovigilance process mastery
The Head of Pharmacovigilance and Regulatory Quality Assurance at CSL Seqirus is responsible for leading global quality and compliance functions within the pharmacovigilance system. This role requires a blend of strategic oversight and operational leadership to ensure compliance with regulations and quality assurance processes

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 that fuels innovation while providing state-of-the-art production facilities globally.

Matching Summary

Match Score: 85

The Head of Pharmacovigilance and Regulatory Quality Assurance at CSL Seqirus is responsible for leading global quality and compliance functions within the pharmacovigilance system. This role requires a blend of strategic oversight and operational leadership to ensure compliance with regulations and quality assurance processes.

Skills & Requirements

Must-have

  • 10+ years pharmaceutical QA experience
  • GVP Module IV regulatory knowledge
  • End-to-end pharmacovigilance process mastery
  • Deviation and CAPA management expertise
  • Global cross-functional team leadership

Nice-to-have

  • Executive presence for global influence
  • Strategic vision alignment with R&D
  • Strong negotiation and communication skills
  • Experience with third-party vendor oversight
  • Continuous improvement initiative implementation

Key Requirements

  • Undergraduate degree in Scientific or Life Sciences
  • Advanced degree preferred
  • Senior leadership capacity proven track record
  • Deep knowledge of GCP and GVP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter