Senior Auditor, Quality Assurance - Sponsor Audits

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.