Manager, Clinical Quality Compliance
Location: United States
Company: ICON Strategic Solutions
Job ID: 2025-120783
Work Mode: Remote
Travel: Up to 50% (domestic/international)
Job Summary
ICON plc, the world’s leading clinical research organization, is hiring a Manager, Clinical Quality Compliance to ensure global GCP compliance across trials, vendors, and internal systems. This fully remote position is ideal for quality leaders experienced in auditing, CAPA oversight, and regulatory standards like ICH E6 and 21 CFR. Join a mission-driven team advancing healthcare through regulatory excellence.
Key Responsibilities
Independently lead GCP audits: clinical sites, internal systems, vendors, and documentation
Prepare and conduct audits, deliver findings, and evaluate CAPAs
Lead post-audit discussions and follow-up assessments
Identify compliance issues and systemic gaps
Contribute to building a proactive quality culture
Mentor junior staff and support auditor development
Collaborate cross-functionally to resolve compliance challenges
Perform additional quality tasks as assigned by leadership
Required Skills & Qualifications
BS/BA with 10+ years or MS with 5+ years in Biotech, Pharma, CRO, or Medical Devices
In-depth knowledge of Good Clinical Practice (GCP) and regulations (ICH E6, 21 CFR Parts 50, 54, 56, 312)
Strong audit experience including GCLP audits
Experience managing vendors or CROs preferred
Vaccine trial background is a plus
Excellent written, verbal, and presentation skills
Capable of influencing and negotiating solutions
Proven leadership and mentoring capabilities
Able to manage multiple projects in a fast-paced setting
Perks & Benefits
Competitive salary (not disclosed)
Generous annual leave options
Comprehensive health insurance (individual and family)
Retirement planning support
Global Employee Assistance Program (TELUS Health)
Life assurance
Flexible country-specific benefits (childcare vouchers, gym discounts, health assessments, travel subsidies, and more)
Company Description
ICON plc is a global leader in clinical research and healthcare intelligence. Supporting pharmaceutical, biotech, and medical device clients, ICON delivers full-service solutions that prioritize regulatory compliance, patient safety, and innovation.
Work Mode
Remote – United States (with up to 50% travel)
Call-to-Action
Join ICON and be part of a global quality team that safeguards clinical research integrity. Apply today for the Manager, Clinical Quality Compliance role to influence quality standards and protect patient outcomes worldwide.
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