Head, Pv And Regulatory Qa

Cslbehring Com Tr

Not specified
Global quality and compliance
Pharmacovigilance system
Regulatory affairs
The Head of Pharmacovigilance and Regulatory Quality Assurance at CSL Behring is responsible for leading the global quality and compliance function of the pharmacovigilance system, ensuring adherence to regulations and standards. The role combines strategic leadership with operational management, focusing on developing compliance frameworks while overseeing daily quality assurance activities

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.
  • Key accountabilities include developing the audit strategy, managing inspections and deviations, and providing GVP consultancy across functional areas.
  • The successful candidate will be a high-calibre Quality Assurance professional with over 10 years of pharmaceutical industry experience and a proven leadership track record.

Matching Summary

Match Score: 85

The Head of Pharmacovigilance and Regulatory Quality Assurance at CSL Behring is responsible for leading the global quality and compliance function of the pharmacovigilance system, ensuring adherence to regulations and standards. The role combines strategic leadership with operational management, focusing on developing compliance frameworks while overseeing daily quality assurance activities.

Skills & Requirements

Must-have

  • global quality and compliance
  • pharmacovigilance system
  • regulatory affairs
  • ICH guidelines
  • GVP Module IV
  • PV health authority inspections

Nice-to-have

  • strategic evolution of PVRQA function
  • cross-functional teams
  • 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

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