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

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

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.

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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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 examples 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.

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

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

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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