Head, Pv And Regulatory Qa

csl.co.th

Not specified
Global quality and compliance
Pharmacovigilance system
Ich guidelines
The Head of Pharmacovigilance and Regulatory Quality Assurance at CSL Seqirus is responsible for overseeing the global compliance function for pharmacovigilance systems, ensuring adherence to regulations and quality standards. This leadership role requires extensive experience in quality assurance within the pharmaceutical industry, focusing on strategic governance, operational excellence, and regulatory intelligence

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.
  • You will direct the strategic development of the Global PVRQA function, supporting both the global R&D business and regional affiliates, 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

Match Score: 85

The Head of Pharmacovigilance and Regulatory Quality Assurance at CSL Seqirus is responsible for overseeing the global compliance function for pharmacovigilance systems, ensuring adherence to regulations and quality standards. This leadership role requires extensive experience in quality assurance within the pharmaceutical industry, focusing on strategic governance, operational excellence, and regulatory intelligence.

Skills & Requirements

Must-have

  • global quality and compliance
  • pharmacovigilance system
  • ICH guidelines
  • audit strategy and governance
  • deviation management
  • CAPA workflows
  • GVP consultancy

Nice-to-have

  • strategic evolution of PVRQA
  • operational delivery
  • compliance roadmap
  • inspection readiness
  • cross-functional expertise
  • continuous improvement initiatives

Key Requirements

  • 10+ years pharmaceutical industry experience
  • Senior leadership capacity
  • Deep knowledge of GVP/GCP regulations
  • Undergraduate degree in Scientific or Life Sciences discipline
  • Proven experience in global, cross-functional teams

Work Rights

Not specified

Tailored Resume

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