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Manager, Clinical Quality Compliance

5-10 years
Not Disclosed
10 July 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.