Senior Auditor - Client Relationship Quality Assurance (CRQA)

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.

We are currently seeking a Principal Auditor Quality Assurance to join our diverse and dynamic team on a 1 year fixed term contract in Client Relationship Quality Assurance (CRQA). As a Principal Auditor CRQA at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of Innovative treatments and therapies for the sponsor companies we support while establishing, building and maintaining successful relationships with our sponsor companies’ counterparts.

What you will be doing

• Relationship Management with internal business partners within ICON and with Sponsor QA counterparts

  • Client communications support

  • Client audit support

  • Client inspections support

• Governance

  • Governance structure development and review of quality data (audits, quality issues, inspections) with sponsor quality counterparts, operations within ICON and at the sponsors

  • ICON Quality &Compliance representation at sponsor and internal partnership meetings

• Risk and issue management

  • Liaise with ICON Q&C functions who carry out the management of quality activities and data (audits, quality issues and inspections)

  • Reviewing quality data managed by ICON Q&C functional teams and tracked in ICON’s Audit Compliance Management System (ACMS), Trackwise Digital, the CRQA Principal Auditor will be responsible for:

    • Quality Risk Mitigation

    • Quality Issue Escalation & Root Cause Analysis

    • Data Analysis & Reporting (Trending, interpretation, analysis)

    • Quality Improvements

• Consultancy

  • QA Consultancy Support

  • GxP Guidance

  • Inspection Readiness

  • Regulation/Requirements Interpretation

  • Contractual Agreements

Your profile

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.

• Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership role.

• In-depth knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).

• Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues.

• Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

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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