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
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like IRE looking for candidates who are engaged and informed.
We think you need these skills to ace Principal Auditor, Quality Assurance
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at IRE. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at IRE
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with IRE’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
