Principal Auditor, Quality Assurance - Office Hybrid in Reading, UK or Dublin, Ireland

Job title: Principal Auditor, Quality Assurance - Office Hybrid in Reading, UK or Dublin, Ireland

About the Role The Principal Auditor, Quality Assurance will lead and execute audits across internal functions and external vendors, with a focus on AI/ML-enabled systems, data integrity, and GxP compliance. This office-hybrid role supports regulatory inspections and client audits while ensuring robust validation and risk-based SDLC practices.

What You'll Do

• 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
• Review and assess Computer System Validation (CSV) deliverables and risk-based validation strategies
• Ensure adherence to Data Integrity principles (ALCOA+)
• Act as SME for CSV and AI; provide guidance to cross-functional teams on compliance, validation, and audit readiness
• Support internal teams and stakeholders during audits, inspections, and system implementations

What We're Looking For

• Strong understanding of GxP regulations (FDA, EU Annex 11, ICH E6) and Computer System Validation (CSV)
• Data Integrity (ALCOA+) and excellent audit, analytical, and risk assessment skills
• Exposure to AI/ML-enabled systems or digital health technologies
• Experience supporting regulatory inspections or sponsor audits
• Strong communication and stakeholder management abilities
• Ability to work in a cross-functional, global environment

Nice to Have

• Experience with AI governance or AI validation approaches (optional but beneficial)

Compensation & Benefits

• Competitive salary and benefits including annual leave entitlements, health insurance, retirement planning
• Global Employee Assistance Programme LifeWorks and Life assurance
• Flexible country-specific benefits
• Additional well-being and family-focused benefits as applicable by location