Principal Auditor, Client Relationships QA

Principal Auditor Quality Assurance

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. We are currently seeking a Principal Auditor Quality Assurance to join our diverse and dynamic team 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 :

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 :

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.