Gvp Vendor Oversight And Qa Lead (eu)

CSL Seqirus

Gvp pharmacovigilance vendor oversight experience
Quality agreement negotiation and maintenance
Capa effectiveness verification and management
This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers across the EU region

Job Summary

  • This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers across the EU region.
  • The successful candidate will lead the end-to-end PV vendor lifecycle, including defining risk-based strategies and managing quality agreements.
  • CSL Seqirus is a major global influenza vaccine provider committed to inclusion, belonging, and pandemic preparedness.

Matching Summary

This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers across the EU region.

Skills & Requirements

Must-have

  • GVP pharmacovigilance vendor oversight experience
  • Quality Agreement negotiation and maintenance
  • CAPA effectiveness verification and management
  • Risk-based qualification strategy for vendors
  • ALCOA+ data integrity principles knowledge
  • EU pharmacovigilance legislation expertise

Nice-to-have

  • Strong stakeholder influencing and negotiation skills
  • Ability to work autonomously in a senior role
  • Postgraduate qualification in scientific discipline
  • Experience with PV inspection readiness support
  • Knowledge of ICH guidance and GVP Modules

Key Requirements

  • 3+ years of GVP or PV quality experience
  • Direct pharmacovigilance vendor oversight background
  • Bachelor's degree in relevant scientific discipline

Work Rights

Not specified

Tailored Resume

Cover Letter