Principal Auditor, Quality Assurance - Homr ot Office-based in Georgia, Poland, Bulgaria, South Africa or UK
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
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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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
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