Principal Auditor, Quality Assurance at ICON plc

Dublin, Leinster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

21 Aug, 26

Salary

0.0

Posted On

23 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Audit Management, Data Integrity, Computer System Validation, AI/ML Validation, GxP Regulations, Risk Assessment, CAPA Implementation, SDLC Practices, Stakeholder Management, Regulatory Inspections, ALCOA+, Quality Assurance

Industry

Biotechnology Research

Description

Principal Auditor, Quality Assurance - Office Hybrid in Reading, UK or Dublin, Ireland 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. 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 #LI-Hybrid #LI-MK2 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 ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Responsibilities

Plan and execute technology, data integrity, and process audits, including specialized audits for AI/ML-enabled systems. Act as a subject matter expert for Computer System Validation (CSV) and provide guidance on compliance and audit readiness.