GVP Vendor Oversight and QA Lead
Core
Lead end-to-end quality oversight of CSL's pharmacovigilance (PV) vendors and service providers, including safety CROs, case processing, and literature monitoring providers.
Role type
Senior quality lead (vendor oversight)
Builds
Quality agreements, KPI/SLA frameworks, governance forums, and CAPA effectiveness checks for PV vendors
Domain
Life sciences / Pharmacovigilance / Regulatory Quality
Required skills
GVP/PV quality oversight, vendor lifecycle management, quality agreement negotiation, risk assessment (FMEA), audit finding analysis, EU GVP Modules knowledge, ICH guidelines, ALCOA+ principles
Preferred skills
Postgraduate qualification in scientific discipline, experience with acquisitions/divestitures due diligence
Technologies
FMEA, risk registers, QMS procedures
Responsibilities
Define risk-based qualification strategy, lead vendor assessments (paper/remote/onsite), draft and maintain quality agreements, establish KPIs/SLAs, lead periodic vendor reviews, set quality standards against EU GVP/ICH, provide input to deviation/CAPA processes, lead inspection readiness, embed quality requirements in contracts, train internal stakeholders
Seniority
Senior, hands-on IC