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Principal Auditor, Quality Assurance
ICON plcPrincipal Auditor, Quality Assurance at ICON responsible for auditing technology and data integrity processes. Collaborating with teams to ensure compliance with GxP regulations and AI validation.
About the role
Key responsibilities & impact- 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 and dataset governance
- Prepare clear, structured audit reports with actionable findings and recommendations
- Support regulatory inspections and client audits
- Review and assess validation deliverables
- Evaluate risk-based validation strategies aligning with industry standards
- Act as a Subject Matter Expert for Computer System Validation (CSV) and AI validation
Requirements
What you’ll need- Strong understanding of GxP regulations (e.g., FDA, EU Annex 11, ICH E6)
- Computer System Validation (CSV) knowledge
- Data Integrity (ALCOA+) expertise
- 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
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Computer System Validation (CSV)Data Integrity (ALCOA+)risk assessmentaudit planningAI lifecycle governancedataset governanceregulatory alignmentvalidation strategiesaudit reportinganalytical skills
Soft Skills
communicationstakeholder managementcross-functional collaborationanalytical skillsaudit skills