Key skills
AIMLStakeholder ManagementCommunication
About this role
Role Overview
- 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
- 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
- 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