CSV Manager
Core
Manage end-to-end Computerized System Validation (CSV) for GxP computerized systems to ensure regulatory compliance and maintain validated states.
Role type
Senior IC Quality/Compliance Manager (CSV)
Builds
Validated GxP computerized systems for healthcare operations
Domain
Healthcare / Life Sciences / Regulatory Compliance
Required skills
GxP regulatory knowledge, CSV lifecycle management, change control management, deviation and CAPA handling, audit preparation, cross-functional team leadership, system inventory management
Preferred skills
Experience in computer science, IT, or engineering fields
Technologies
GxP computerized systems, QMS tools
Responsibilities
Prepare, execute, and report GxP CSV deliverables; ensure compliance with regulatory requirements; maintain validated state of systems; oversee project implementation and escalations; conduct periodic reviews; provide training on CSV procedures; manage QMS activities (Change Controls, Deviations, CAPAs); prepare for and participate in audits; maintain system inventory
Seniority
Senior, hands-on IC