Senior Auditor, Quality Assurance

ICON Clinical Research, LP

Blue Bell, PA, US
Not specified; not specified; competitive salary w...
Fully remote
Experience hosting external audits
Capa management expertise
Root cause analysis skills
The Audit Defense team leads client audits globally for ICON's clinical, PV, and technology services while serving as the central point of contact for external auditors

Job Summary

  • The Audit Defense team leads client audits globally for ICON's clinical, PV, and technology services while serving as the central point of contact for external auditors.
  • This role requires leading CAPA management for sponsor audits and ensuring timely completion of responses in compliance with ICON or Sponsor SOP requirements.
  • ICON offers a competitive salary, diverse benefits including health insurance and retirement planning, and a culture dedicated to inclusion and belonging.

Matching Summary

The Audit Defense team leads client audits globally for ICON's clinical, PV, and technology services while serving as the central point of contact for external auditors.

Salary

Not specified; Not specified; Competitive salary with range of additional benefits

Skills & Requirements

Must-have

  • Experience hosting external audits
  • CAPA management expertise
  • Root cause analysis skills
  • Clinical data review ability
  • GCP guidelines knowledge

Nice-to-have

  • Excellent communication skills
  • Ability to work independently under pressure
  • Willingness to travel occasionally
  • Strong problem resolution skills

Key Requirements

  • 3 to 6 years of experience
  • Knowledge of drug development process
  • Understanding of regulatory requirements

Work Rights

Not specified

Tailored Resume

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