Head, Pv And Regulatory Qa

CSL SEQIRUS

Multiple Locations
Global quality and compliance
Pharmacovigilance system oversight
Ich guidelines compliance
The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system, ensuring compliance with global regulations, ICH guidelines, and company standards

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, ICH guidelines, and company standards.
  • This role directs the strategic development of the Global PVRQA function, focusing on Strategic Governance, Operational Excellence, and Regulatory Intelligence.
  • The successful candidate will be a high-calibre Quality Assurance professional with the executive presence to influence global cross-functional teams and the technical depth to safeguard our Pharmacovigilance system.

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, ICH guidelines, and company standards.

Skills & Requirements

Must-have

  • global quality and compliance
  • pharmacovigilance system oversight
  • ICH guidelines compliance
  • risk-based audit strategy
  • health authority inspections
  • deviation management
  • CAPA workflows

Nice-to-have

  • strategic leadership
  • cross-functional expertise
  • continuous improvement initiatives
  • executive presence
  • customer service focus

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter