Principal Auditor, Quality Assurance - CSV, AI & Risk Assessment

ICON Clinical Research; Dublin; On-site; 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

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

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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

Your Profile:

• Strong understanding of:
  • GxP regulations (e.g., FDA, EU Annex 11, ICH E6)
  • Computer System Validation (CSV)
  • Data Integrity (ALCOA+)
• 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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)