Global Quality GVP Manager
Core
Ensure quality oversight and assurance for Global Vaccines Portfolio (GVP) processes, vendors, partners, and affiliates, including managing audit strategies and programs.
Role type
Senior Quality Assurance Manager (GVP/PV)
Builds
End-to-end audit management processes and quality assurance frameworks for GVP regulated areas.
Domain
Pharmaceutical industry, Vaccines, Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GVP audit management, PV process oversight, vendor/partner qualification, CAPA assessment, SOP authoring, risk assessment, regulatory compliance (EU/US/RoW), cross-functional collaboration
Preferred skills
Auditing experience, QA systems expertise, contract review for PV provisions
Technologies
None stated
Responsibilities
Develop audit strategy and plans for GVP area; Perform and coordinate internal and external PV audits; Assess and approve PV deviations and CAPAs; Author QA processes and review PV-related SOPs; Manage audit trends and prepare status reports; Qualify service providers and review PV provisions in contracts; Act as QA representative in PV inspections.
Seniority
Senior, hands-on IC
