At a Glance
- Tasks: Lead audits on tech and data integrity, ensuring compliance and quality across systems.
- Company: Join ICON, a global leader in healthcare intelligence and clinical research.
- Benefits: Enjoy competitive salary, health coverage, and career development opportunities.
- Other info: Work in a hybrid environment with a focus on inclusion and collaboration.
- Why this job: Make a real impact in healthcare by ensuring the integrity of innovative technologies.
- Qualifications: Strong understanding of GxP regulations and experience with AI/ML systems.
The predicted salary is between 60000 - 75000 € per year.
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
- Act as an SME for:
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
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.
Principal Auditor, Quality Assurance employer: IRE
ICON is an exceptional employer that prioritises integrity, collaboration, and inclusion, making it a fantastic place for professionals in the healthcare intelligence and clinical research sector. With a hybrid work model in Reading or Dublin, employees benefit from a competitive salary, comprehensive health and wellbeing programmes, and robust learning and development opportunities, all within a supportive and values-driven culture. Join us to contribute to meaningful advancements in patient care while enjoying a fulfilling career path.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Auditor, Quality Assurance
✨Tip Number 1
Network like a pro! Reach out to folks in your industry on LinkedIn or at events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by researching the company and its values. Show us how your skills align with our mission at ICON, and don’t forget to have some questions ready!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable talking about your experience and skills.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, you’ll find all the latest roles we have available.
We think you need these skills to ace Principal Auditor, Quality Assurance
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience with GxP regulations and Computer System Validation. We want to see how your skills align with the role of Principal Auditor, so don’t hold back!
Showcase Your Audit Skills:When writing your application, emphasise your audit management and execution experience. Share specific examples of audits you've conducted, especially those involving AI/ML systems, as this will really catch our eye.
Be Clear and Concise:We appreciate straightforward communication! Keep your application clear and to the point, focusing on your key achievements and how they relate to the job description. This helps us quickly see your fit for the role.
Apply Through Our Website:Don’t forget to submit your application through our careers site! It’s the best way for us to receive your details and ensures you’re considered for the position. We can’t wait to hear from you!
How to prepare for a job interview at IRE
✨Know Your GxP Regulations
Make sure you brush up on GxP regulations like FDA and EU Annex 11. Being able to discuss these in detail will show your understanding of the industry standards and how they apply to the role.
✨Showcase Your Audit Skills
Prepare examples of past audits you've conducted, especially those involving AI/ML systems or data integrity. Highlight your analytical skills and how you’ve developed actionable findings from your audits.
✨Demonstrate Cross-Functional Collaboration
Since this role involves working with various teams, be ready to share experiences where you successfully collaborated across functions. This will illustrate your ability to work in a global environment and manage stakeholders effectively.
✨Prepare for Technical Questions
Expect questions about Computer System Validation (CSV) and risk assessment strategies. Brush up on your knowledge and be prepared to discuss how you would approach these tasks in real-world scenarios.
