Head, Pv And Regulatory Qa

CSL Seqirus

Multiple Locations
Global quality and compliance leadership
Pharmacovigilance system oversight
Audit strategy and governance
The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system, ensuring compliance with global regulations

Job Summary

  • The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system, ensuring compliance with global regulations.
  • Key accountabilities include developing the audit strategy, managing inspections, overseeing deviation management, CAPA, and change management, and providing GVP consultancy.
  • The successful candidate will be a high-calibre Quality Assurance professional with executive presence and technical depth, possessing 10+ years of pharmaceutical industry experience within Quality Assurance.

Matching Summary

The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system, ensuring compliance with global regulations.

Skills & Requirements

Must-have

  • Global quality and compliance leadership
  • Pharmacovigilance system oversight
  • Audit strategy and governance
  • Inspection and deviation management
  • GVP consultancy and cross-GxP expertise

Nice-to-have

  • Strategic evolution of PVRQA function
  • Continuous improvement initiatives
  • Customer service focus

Key Requirements

  • 10+ years pharmaceutical industry experience
  • Senior leadership capacity experience
  • Deep knowledge of GVP/GCP regulations
  • Undergraduate degree in Scientific or Life Sciences

Work Rights

Not specified

Tailored Resume

Cover Letter