Found Description
Key Responsibilities
- 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 external vendors, integrations and interfaces
- Support dataflow mapping and transfer controls
- Drive continuous improvement aligned with ICH E6(R3) and EMA expectations