Sr. QA Computer System Validation Mgr.
Core
Overseeing validation, compliance, and lifecycle management of GxP computer systems (clinical, quality, lab, enterprise, manufacturing) to ensure regulatory adherence and support business objectives.
Role type
Senior QA Computer System Validation Manager
Builds
Validated GxP computer systems for clinical trials, quality, and manufacturing
Domain
Biopharmaceutical / Clinical Development / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP computer system validation, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines, data integrity controls, risk-based validation strategies, IT change management, audit support, vendor qualification
Preferred skills
Experience with IRT, EDC, eTMF systems, enterprise/quality/lab/clinical system validation, regulatory inspection readiness
Technologies
IRT, EDC, eTMF, GxP systems
Responsibilities
Provide QA oversight for GxP computer systems lifecycle; Review and approve CSV deliverables, IT change requests, and quality records; Serve as SME for CSV requirements and regulatory standards; Support audits for IT vendor qualification; Collaborate on inspection readiness initiatives
Seniority
Senior, hands-on IC