QA/Computer System Validation SME

QA/CSV SME
MUST haves - Clinical Systems Validation (Veeva eTMF, Medidata Rave, Clinical Data Repositories)

• Provide QA oversight for Computer System Validation (CSV) activities across GxP-regulated clinical and biopharmaceutical systems, ensuring compliance with FDA 21 CFR Part 11, GAMP 5, and applicable regulatory requirements.
• Review and approve validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ protocols, Test Scripts, Traceability Matrices, and Validation Summary Reports.
• Partner with Business, IT, Clinical Operations, and Quality stakeholders to perform risk-based assessments, identify compliance gaps, and implement effective mitigation strategies.
• Support end-to-end validation lifecycle activities for clinical platforms, including system implementations, upgrades, integrations, cloud migrations, and change controls.
• Lead and support vendor qualification assessments, supplier audits, and third-party compliance evaluations to ensure validated system integrity and regulatory compliance.
• Ensure inspection readiness by maintaining validation documentation, supporting regulatory audits, and providing responses to FDA, EMA, MHRA, and internal quality inspections.
• Provide QA guidance and oversight for deviations, incidents, CAPAs, change controls, periodic reviews, and validation exceptions throughout the system lifecycle.
• Develop, review, and maintain CSV-related SOPs, policies, work instructions, templates, and validation standards to support a compliant quality framework.
• Collaborate with cross-functional teams to establish validation strategies, testing approaches, and data integrity controls based on risk and business impact.
• Drive continuous process improvements by implementing industry best practices, CSA (Computer Software Assurance) principles, and risk-based validation methodologies.
• Manage multiple CSV projects simultaneously, ensuring deliverables are completed on schedule while maintaining compliance and quality standards.
• Support governance of clinical applications such as CTMS, eTMF, EDC, Safety Systems, ePRO, LMS, and other GxP-regulated platforms.
• Conduct Data Integrity assessments and ensure compliance with ALCOA+ principles, electronic records, electronic signatures, and audit trail requirements.
• Coordinate internal and external resources, monitor project progress, and provide status updates to QA leadership and project stakeholders.
• Mentor project teams on validation compliance expectations and promote a culture of quality, regulatory adherence, and continuous improvement.