Assess and document Data Integrity risks associated with externally operated systems and the interfaces linking them to internal systems, ensuring that controls are in place to protect data reliability, and traceability. * Solid knowledge of GLP, GCP, GVP and GRA regulatory frameworks and associated expectations for computerized systems (e.g., OECD GLP, ICH E6(R3), EU GVP Module I/IX). Our partner is looking for a R&D and Pharmacovigilance Digital Quality lead to join its team. * Ensure GLP, GCP, GVP and GRA business systems are fully compliant with regulatory expectations (e.g. OECD, ICH, GVP) and internal digital governance requirements. * Maintain and evolve the compliance framework for GxP-relevant systems (policies, SOPs, guidance). * Provide QA insight during system selection, onboarding, validation, and ongoing oversight. * Support investigations, deviations, CAPAs, and ...
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