Senior Auditor, Quality Assurance - Sponsor Audits

Senior Auditor, Quality Assurance - Remote in Poland, Bulgaria or South Africa

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.

The opportunity:

The Audit Defense team are seeking an individual to join them as a Senior QA Auditor position.  This is a great opportunity for someone with a clinical background to develop their career within Quality Assurance.

This is a specialized team responsible for leading external/client audits of ICON globally for our clinical, PV and technology services.

The team work directly with the client auditors to arrange, prepare for and host the external audit, liaising with the internal ICON team to ensure the client audit expectations are met and that the audit is a success. The team also manage any resulting observations and CAPAs which ensures the external auditor has one central point of contact for the duration of the audit through to closure. 

This role will focus on leading investigations, root cause analysis, and CAPA management activities associated with external/client audits of ICON, ensuring effective remediation, regulatory compliance, and continuous improvement across ICON's quality management system.

The Audit Defense team have many years’ experience of hosting both on-site audits conducted at ICON facility, as well as hosting remote audits using technology available to ensure the audit scope can still be met remotely. 

Key responsibilities:

•    Lead and support external/client audits of ICON including scheduling, preparation and hosting.
•    Lead CAPA management for external/client audits of ICON, in order to assure responses are compliant with ICON or Sponsor SOP requirements.
•    Partner with operational teams to develop, review, and finalize audit responses, ensuring timely completion of commitments, implementation of effective corrective and preventive actions, and successful resolution of follow-up requests within agreed timelines

•    Lead quality issue investigations and facilitate robust root cause analyses to identify systemic issues and drive sustainable corrective and preventive actions

•    Oversee the full CAPA lifecycle, ensuring CAPAs are appropriately documented, tracked, escalated when necessary, and closed in a timely and compliant manner.

•    Monitor CAPA effectiveness activities, including identification, tracking, and completion of effectiveness checks to verify long-term resolution and prevent recurrence.

•    Provide expert guidance to operational teams on CAPA development, root cause analysis methodologies, GCP compliance, and regulatory expectations to support inspection readiness and continuous improvement.

•    Analyze CAPA trends and quality metrics to identify recurring issues, support risk-based decision-making, and drive enhancements to quality systems and operational processes.

•    Collaborate with cross-functional stakeholders to strengthen quality culture and ensure consistent application of investigation and CAPA management processes across the organization.

•    Support broader Quality & Compliance initiatives, including conducting internal, investigator site, and vendor audits as required to meet business and regulatory needs.

To be successful in the role, you will have:

•    BSc Degree is required.

•    Knowledge/experience in CAPA management, including performing effective root cause analysis.

•    Knowledge/experience in hosting external/client audits and/or regulatory inspections.
•    Ability to review and evaluate clinical data/records.
•    Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
•    Detailed understanding of drug development and clinical trial process.
•    Good problem resolution skills.
•    Good planning and organizational skills with the ability to multi-task and prioritize effectively.
•    Ability to work efficiently and independently under pressure.
•    Ability and willingness to travel on occasion to accommodate the client.
•    Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.

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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