JR152125 Principal Auditor, Quality Assurance - CSV, AI & Risk Assessment - Mexico - Homebased
ICON is a integral healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Principal Auditor, Quality Assurance at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will 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




- 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:
- Computer System Validation (CSV)
- Risk-based SDLC practices
- 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

You

📌 Principal Auditor, Quality Assurance (Ciudad de México)
🏢 IRE
📍 Ciudad de México