Senior GCP Auditor - USA (Home-Based with Travel)
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 have an incredible opportunity for a Senior Auditor, GCP Quality Assurance to join ICON’s Full Service Quality & Compliance team. The Senior Auditor, Quality Assurance will conduct investigator site audits and supplier audits in the United States.
Location: USA (home-based) with up to 35% Domestic Travel
What you will be doing:
- Lead and conduct audits of clinical trial processes, systems, and documentation to ensure regulatory compliance
- Conducting internal and vendor audits, external audits/Regulatory Authority inspections management, SOP and documentation review, and CAPA management
- Collaborate with cross-functional teams to improve QA systems and practices
- Develop and implement audit plans, conduct internal, vendor, and regulatory audits, and manage CAPAs
- Provide training, mentorship, and guidance on QA standards and regulatory requirements
- Support business development efforts and contribute to continuous improvement initiatives
- Track and report audit findings, manage QA documentation, and oversee CAPA effectiveness, trending, and resolution of quality issues including serious breaches or misconduct
- Ensure ICON’s QMS tracking system is updated with the appropriate information and documentation
Your profile:
- 5 years of experience in quality assurance at either a clinical research organization or sponsor with a focus on Good Clinical Practice (GCP)
- 2 years of experience in either a senior or lead role
- In-depth knowledge of regulatory requirements and guidelines governing clinical trials (ICH-GCP)
- Strong communication skills
- Detail oriented with organizational skills
- Ability to work both independently and as a team
- Bachelors Degree required
- Medical background or BSN preferred
- Ability to travel up to 35% with proximity to an airport
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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
