FSP Quality Manager
Core
Operational execution of the Pharmacovigilance (PV) Quality Management System (QMS) to ensure consistent, effective, and efficient patient safety operations.
Role type
Senior IC Quality Manager (Pharmacovigilance)
Builds
PV Quality Management System, training programs, procedural documents, and audit readiness
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GXP quality and compliance management, audit and inspection readiness, CAPA and root cause analysis, procedural document development, KPI development, training program management, stakeholder collaboration
Preferred skills
Experience with Veeva System, global regulatory knowledge (Europe, US, Japan), cross-functional leadership
Technologies
Veeva System, Microsoft Office, tracking databases
Responsibilities
Manage GVP audit and inspection activities including preparation and response coordination; Assess issue management trends and lead implementation of corrective and preventive actions; Develop, maintain, and deliver pharmacovigilance training programs and procedural documents; Monitor compliance with contractual obligations, PVAs, and SOPs; Contribute to KPI development and continuous improvement initiatives
Seniority
Senior, hands-on IC
