Principal Auditor - Client Relationship Quality Assurance (crqa)

ICON Clinical Research, LP

Georgia, United States
Not specified; competitive within each country; va...
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7 years qa experience in pharma or cro
3 years leadership role in quality assurance
In-depth knowledge of ich-gcp and fda regulations
** ICON Clinical Research is seeking a Principal Auditor for Client Relationship Quality Assurance (CRQA), a hybrid role focused on ensuring quality and compliance in clinical trials while fostering relationships with sponsor companies. The ideal candidate will have extensive experience in quality assurance within the pharmaceutical or biotechnology sectors and strong analytical and communication skills. **

Job Summary

  • The Principal Auditor will play a pivotal role in ensuring the quality and compliance of clinical trials while building successful relationships with sponsor companies.
  • Responsibilities include managing quality data, performing root cause analysis, and providing consultancy support on regulatory requirements and inspection readiness.
  • ICON offers a competitive salary, diverse benefits including health insurance and retirement planning, and a culture dedicated to inclusion and belonging.

Matching Summary

Match Score: 75

** ICON Clinical Research is seeking a Principal Auditor for Client Relationship Quality Assurance (CRQA), a hybrid role focused on ensuring quality and compliance in clinical trials while fostering relationships with sponsor companies. The ideal candidate will have extensive experience in quality assurance within the pharmaceutical or biotechnology sectors and strong analytical and communication skills. **

Salary

Not specified; Competitive within each country; Various annual leave entitlements; Health insurance offerings; Retirement planning offerings

Skills & Requirements

Must-have

  • 7 years QA experience in pharma or CRO
  • 3 years leadership role in quality assurance
  • In-depth knowledge of ICH-GCP and FDA regulations
  • Experience with ACMS and Trackwise Digital systems
  • Root cause analysis and risk mitigation skills

Nice-to-have

  • Advanced degree in Life Sciences or Pharmacy
  • Strong stakeholder communication abilities
  • Consultancy support for GxP guidance
  • Ability to work in hybrid or remote settings
  • Experience with sponsor inspection readiness

Key Requirements

  • Bachelor's degree in Life Sciences or related field
  • Minimum 7 years QA experience in pharmaceutical/biotech/CRO
  • At least 3 years in a leadership role
  • Knowledge of ICH-GCP and FDA regulations

Work Rights

Not specified

Tailored Resume

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