Provide QA insight during system selection, onboarding, validation, and ongoing oversight. * Oversee the validation and lifecycle control of external computerized systems used by CROs or third-party service providers, ensuring they meet internal quality and regulatory expectations. * Collaborate with other QA teams and business stakeholders to define validation requirements, risk-based controls, and deliverables for external systems that generate or process GxP data. * Ensure appropriate documentation (URS, validation packages, data flows) is in place for external systems supporting clinical studies and activities. * Participate in vendor assessments with a focus on system integrity, validation, and compliance evidence. * Strong understanding of Computerized System Validation (CSV) principles, including risk-based approaches and system lifecycle activities.
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