The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function ensuring end-to-end PV processes remain compliant 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 ensuring end-to-end PV processes remain compliant with global regulations, ICH guidelines, and company standards.
The role combines strategic oversight with operational leadership including designing audit strategies, managing inspections, deviation management, and quality controls across the business.
CSL Seqirus is a leading influenza vaccine provider with global production facilities and a strong commitment to inclusion, belonging, and pandemic preparedness.
Matching Summary
The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function ensuring end-to-end PV processes remain compliant with global regulations, ICH guidelines, and company standards.
Skills & Requirements
Must-have
Pharmacovigilance system compliance
Risk-based audit strategy
Deviation and CAPA management
Global regulatory inspection management
Cross-functional GxP expertise
Operational quality assurance oversight
Nice-to-have
Strategic governance and leadership
Continuous improvement initiatives
Excellent communication and influence skills
Global cross-functional team collaboration
Budget and resource management
Key Requirements
Undergraduate degree in Scientific or Life Sciences discipline
10+ years pharmaceutical Quality Assurance experience
Senior leadership experience in GVP/GCP regulations