Provide QA insight during system selection, onboarding, validation, and ongoing oversight. * Collaborate with other 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. End-to-End Data Integrity (DI) Governance & Compliance * Ensure end-to-end Data Integrity across all GxP-relevant data flows, from initial data capture in external partner systems through all transformations, transfers, and integrations into the company-owned environments. * Work with Computer System QA team and Clinical Operations to ensure that DI controls (including ALCOA+ principles, metadata management, audit trails, system-to-system data transfer checks, and ...
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