Major Accountabilities
- Validation Lifecycle Management: Lead and support the full validation lifecycle for GxP and other regulated IT systems, including planning, execution, change control, documentation, periodic system reviews, retrospective system reviews when required, and continuous improvement.
- Protocol Development & Risk Assessment: Work with MoonLake system owners to develop and execute validation protocols, risk assessments, and test plans for systems subject to GxP, SOX, ISO27001, and related standards.
- Vendor Oversight: Oversee and review vendor validation and computer system assurance activities and due diligence to ensure compliance with internal and external requirements.
- Documentation & Audit Readiness: Maintain comprehensive validation documentation, ensuring systems are audit-ready and compliant throughout their lifecycle.
- Periodic and Retrospective Reviews: Coordinate and perform periodic reviews of validated and critical systems to confirm continued compliance, intended use, data integrity, access controls, change history, incident records, and vendor performance. Conduct retrospective system reviews when needed, such as after major changes, deviations, audit findings, business process changes, or when systems have not been reviewed or validated to the expected standard.
- Audit & Inspection Support: Act as a subject matter expert during audits and regulatory inspections, providing validation evidence and guidance.
- Cross-Functional Collaboration: Work closely with IT, QA, Finance, Clinical Operations, other departments and vendors to ensure ongoing compliance, data integrity, business continuity planning, disaster recovery, and security for all validated systems.
- Training & Guidance: Provide training and guidance on CSV processes, documentation, and regulatory requirements to relevant stakeholders.