Key Responsibilities
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* Ensure compliance of GLP, GCP, GVP and Regulatory Affairs systems
* Maintain compliance frameworks, SOPs, policies and guidance
* Support system selection, onboarding, validation and oversight
* Manage deviations, investigations, CAPAs and inspection-readiness activities
* Provide QA oversight for computerized systems lifecycle activities
Data Integrity Governance
* Ensure end-to-end Data Integrity across clinical and PV data flows
* Implement ALCOA+ principles, audit trails and metadata controls
* Assess DI risks across xphnsxz external vendors, integrations and interfaces
* Support dataflow mapping and transfer controls
* Drive continuous improvement aligned with ICH E6(R3) and EMA expectations