CSV Validation Lead
Core
Overseeing the lifecycle validation of computer systems to ensure compliance with global regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11) and maintaining data integrity.
Role type
Senior CSV Validation Lead
Builds
Validated IT systems for regulated industries (lab equipment, enterprise ERPs, clinical trial systems)
Domain
Life Sciences / Regulated Industries / IT Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP regulatory knowledge (FDA 21 CFR Part 11, EU Annex 11, GAMP 5), risk-based testing strategy, validation framework development, IQ/OQ/PQ testing management, data integrity (ALCOA+) expertise, vendor technical auditing, change control management
Preferred skills
CISA, CSQE, or GAMP 5 training certification
Technologies
SAP S/4HANA, LIMS, QMS (TrackWise/Veeva), MES, SaaS/Cloud platforms
Responsibilities
Develop and maintain the Validation Master Plan (VMP), lead creation of validation deliverables (URS, Risk Assessments, Validation Plans), manage execution of IQ/OQ/PQ testing, act as SME for ALCOA+ principles, support internal and external regulatory audits, perform technical audits of software vendors, review and approve system changes
Seniority
Senior, hands-on IC with leadership capacity