Head, Pv And Regulatory Qa

Centerforintegrationscience

**
10+ years pharmaceutical qa experience
Global gvp and ich guideline expertise
End-to-end pharmacovigilance process management
** The Head of Pharmacovigilance and Regulatory Quality Assurance at CSL Seqirus is responsible for leading the quality and compliance functions within the pharmacovigilance system, ensuring adherence to global regulations. The role combines strategic oversight with operational leadership, requiring extensive experience in quality assurance and pharmacovigilance processes. **

Job Summary

  • The role leads the global quality and compliance function for the pharmacovigilance system ensuring adherence to international regulations.
  • Candidates must possess a proven track record in senior leadership with deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines.
  • CSL Seqirus offers a culture of inclusion and belonging that fuels innovation while providing state-of-the-art production facilities across multiple continents.

Matching Summary

Match Score: 75

** The Head of Pharmacovigilance and Regulatory Quality Assurance at CSL Seqirus is responsible for leading the quality and compliance functions within the pharmacovigilance system, ensuring adherence to global regulations. The role combines strategic oversight with operational leadership, requiring extensive experience in quality assurance and pharmacovigilance processes. **

Skills & Requirements

Must-have

  • 10+ years pharmaceutical QA experience
  • Global GVP and ICH guideline expertise
  • End-to-end pharmacovigilance process management
  • Audit strategy and inspection leadership
  • Deviation and CAPA workflow oversight

Nice-to-have

  • Strategic influence on cross-functional teams
  • Experience with third-party vendor management
  • Knowledge of GCP, GDP, and GCLP standards
  • Budget development and resource stewardship

Key Requirements

  • Undergraduate degree in Scientific or Life Sciences
  • 10+ years industry tenure in Quality Assurance
  • Senior leadership capacity in PV systems

Work Rights

Not specified

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