Director - Computer Systems Validation
Core
Director of Computer Systems Validation Program providing oversight of validation teams to ensure on-time, on-budget delivery of CSV activities for Veeva Vault technology in the life sciences industry.
Role type
Senior IC/Manager Computer Systems Validation Director
Builds
Veeva Vault technology (SaaS) for life sciences companies
Domain
Life Sciences / Regulated Software (GxP)
Deliverable
production ML models
Required skills
Computer Systems Validation (CSV), GxP regulatory compliance (GMP, GCP, GLP, GvP), 21 CFR Part 11, risk-based validation, team leadership, project management, audit support, change management, document control
Preferred skills
AI/ML validation, automated testing, Agile SDLC, ISO/SEI/ITIL frameworks, global health authority experience (FDA, EMA)
Technologies
Veeva Vault, SaaS, AI/ML, Cloud
Responsibilities
Manage/mentor validation program managers and team leads; deliver validation projects under strict deadlines; establish validation processes commensurate with risk; oversee on-shore and off-shore validation contractors; act as executive interface between Product Development, Operations, Security, and QA/Compliance; support planning and execution of periodic reviews.
Seniority
Director, strategic oversight & team leadership