Senior Auditor, QA & AI Validation (Hybrid)

ICON Clinical Research; Dublin; Hybrid; EUR 82,169 - 129,123; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global EAP LifeWorks

Life assurance

Country-specific optional benefits

Job summary

ICON plc is a leading healthcare intelligence and clinical research organization, offering a hybrid work model with offices in Reading, UK or Dublin, Ireland. The Principal Auditor, Quality Assurance, will lead audits across internal and external functions, ensure data integrity, and support AI/ML validation and regulatory inspections in a global setting.

The role emphasizes risk-based auditing, ALCOA+ data principles, and cross-functional collaboration.

Qualifications

• Strong understanding of GxP regulations (FDA, EU Annex 11, ICH E6).
• Excellent audit, analytical, and risk assessment abilities.
• Exposure to AI/ML-enabled systems or digital health technologies.
• Experience supporting regulatory inspections or sponsor audits.

Responsibilities

• Audit management & execution across internal functions and external vendors.
• Develop risk-based audit plans and regulatory-aligned scope.
• Audit AI/ML systems lifecycle: development, validation, deployment, monitoring.
• Prepare structured audit reports with actionable findings and CAPA follow-up.
• Support regulatory inspections and client audits.

Skills

Audit management

Analytical skills

Regulatory knowledge

AI/ML awareness

Stakeholder management

Tools

CSV validation

Job description

ICON plc is a leading healthcare intelligence and clinical research organization, offering a hybrid work model with offices in Reading, UK or Dublin, Ireland. The Principal Auditor, Quality Assurance, will lead audits across internal and external functions, ensure data integrity, and support AI/ML validation and regulatory inspections in a global setting.

The role emphasizes risk-based auditing, ALCOA+ data principles, and cross-functional collaboration.