Business System Validation Senior Specialist
Core
Lead enterprise-wide validation strategies for data integration and automation solutions supporting clinical and business operations, ensuring regulatory compliance and inspection readiness.
Role type
Senior IC business system validation specialist
Builds
Validated data integration and automation systems for clinical and business operations
Domain
Life Sciences / Clinical Data Management / Regulatory Compliance
Required skills
Risk-based validation planning, GxP compliance (21 CFR Part 11, GCP), CAPA management, Root cause analysis, Test strategy development, Audit readiness, Validation lifecycle management, Enterprise test tools, Data quality assurance, Stakeholder coordination
Preferred skills
AI-augmented validation frameworks, Model governance, Advanced validation strategies
Technologies
Enterprise test management tools, Automation platforms
Responsibilities
Lead end-to-end execution of complex system validation activities; Develop advanced validation strategies and risk assessments; Oversee test execution and defect management; Provide expert review and approval for validation deliverables; Mentor junior validation staff; Monitor and report validation KPIs
Seniority
Senior, hands-on IC with strategic oversight
