About this role
About the Role ICON is seeking a Principal Auditor, Quality Assurance with a focus on CSV, AI & Risk Assessment to ensure quality and regulatory compliance of clinical trials and AI-enabled systems. The role involves leading audits across internal functions and external vendors, developing risk-based audit plans, and supporting regulatory inspections. What You'll Do
- Audit Management & Execution: Plan, schedule, and conduct technology, data integrity, and process audits across internal functions and external vendors. Develop risk-based audit plans, defining scope, audit approach, and regulatory alignment. Conduct audits of AI/ML-enabled systems, including AI lifecycle (development, validation, deployment, monitoring), dataset governance and model evaluation, and human oversight and quality control mechanisms. Prepare clear, structured audit reports with actionable findings and recommendations. Track and verify CAPA implementation and effectiveness. Support regulatory inspections and client audits.
- Computer System Validation (CSV) & Risk Assessment: Review and assess validation deliverables. Evaluate risk-based validation strategies in line with industry standards. Conduct GxP impact and risk assessments to ensure appropriate validation scope. Ensure adherence to Data Integrity principles (ALCOA+).
- Subject Matter Expertise (SME) – CSV & AI: Act as an SME for CSV, risk-based SDLC practices, and AI validation and governance approaches. Provide guidance to cross-functional teams on compliance, validation, and audit readiness. Support internal teams and stakeholders during audits, inspections, and system implementations.