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

JR152125 Principal Auditor, Quality Assurance - CSV, AI & Risk Assessment - Mexico - Homebased

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Principal Auditor, Quality Assurance at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

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:

  • GCP Regulations (e.g., FDA Regulations [21 CFR], ICH E6) - NOT GMO, GLP, GDP

  • 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}

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply