The role requires leading the independent quality authority function to ensure global compliance with ICH guidelines and company standards
Job Summary
The role requires leading the independent quality authority function to ensure global compliance with ICH guidelines and company standards.
Candidates must own the long-term risk-based audit strategy aligned with GVP Module IV while managing day-to-day operational quality controls.
The position involves directing strategic evolution of the PVRQA function while simultaneously managing inspections, deviation management, and rigorous CAPA workflows.
Matching Summary
The role requires leading the independent quality authority function to ensure global compliance with ICH guidelines and company standards.
Skills & Requirements
Must-have
10+ years pharmaceutical QA experience
Global GVP Module IV audit strategy
End-to-end pharmacovigilance process knowledge
Deviation and CAPA management expertise
Health authority inspection leadership
Nice-to-have
Executive presence for cross-functional influence
Advanced degree in Life Sciences
Experience with third-party vendor management
Knowledge of GCP GDP and GCLP standards
Key Requirements
Undergraduate degree in Scientific or Life Sciences discipline
10+ years of pharmaceutical industry Quality Assurance experience
Proven senior leadership track record in PV/GxP regulations