Senior GCP Auditor – Remote (USA)
Location: United States (Remote-Based)
Travel: Up to 35% Domestic
Company: ICON plc
Job Summary
ICON plc, a global leader in clinical research and healthcare intelligence, is hiring a Senior GCP Auditor to join its Full-Service Quality & Compliance team. This home-based role involves performing clinical trial site and vendor audits across the U.S., ensuring GCP and regulatory compliance. If you are passionate about driving quality and regulatory excellence in clinical trials, this is your opportunity to lead change in a top-tier organization.
Key Responsibilities
Lead and conduct internal, investigator site, and supplier GCP audits
Ensure compliance with ICH-GCP and regulatory guidelines across clinical trial processes
Manage regulatory inspections, SOP reviews, and CAPA implementation
Collaborate across departments to enhance QA systems
Guide, mentor, and train teams on QA and regulatory standards
Maintain ICON’s QMS with audit documentation and outcomes
Support audit reporting, CAPA tracking, and resolution of quality issues
Contribute to business development and process improvement initiatives
Required Skills & Qualifications
Minimum 5 years of QA experience in clinical research (CRO or sponsor)
At least 2 years in a senior or lead QA role
Expertise in ICH-GCP and global clinical trial regulations
Bachelor's degree required; BSN or medical background preferred
Strong communication and documentation skills
Organized and detail-oriented with a collaborative mindset
Willingness to travel domestically up to 35%
Must reside near a major U.S. airport
Perks & Benefits
Competitive base salary
Various annual leave entitlements
Comprehensive health insurance packages
Competitive retirement savings plans
Global Employee Assistance Program (LifeWorks)
Life assurance coverage
Flexible benefits including gym discounts, travel subsidies, and wellness programs
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization, supporting pharmaceutical, biotech, and medical device companies in accelerating drug development. Our inclusive culture values innovation, excellence, and continuous learning across a global network.
Work Mode
Remote (USA-based) with up to 35% domestic travel
Call to Action
Are you a QA expert with GCP experience ready to elevate your career with a global CRO leader? Apply now to join ICON’s mission to shape the future of clinical development.
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