Sr. Clinical Qa Auditor

IQVIA

Washington, DC, United States
Base: $75,400.00 - $188,600.00; bonus/equity: ince...
Fully remote
Gcp compliance expertise
Lead gcp audits
Investigator site audits
The Sr. Clinical QA Auditor will serve as a subject matter expert in GCP compliance, driving audit strategy, inspection readiness, and continuous quality improvement

Job Summary

  • The Sr. Clinical QA Auditor will serve as a subject matter expert in GCP compliance, driving audit strategy, inspection readiness, and continuous quality improvement.
  • Responsibilities include leading and executing GCP audits of investigator sites, vendors, internal systems, and sponsors, as well as performing TMF quality reviews.
  • The role requires experience in clinical quality assurance, auditing, or clinical operations within a CRO, pharma, or biotech environment, with medical device experience being mandatory.

Matching Summary

The Sr. Clinical QA Auditor will serve as a subject matter expert in GCP compliance, driving audit strategy, inspection readiness, and continuous quality improvement.

Salary

Base: $75,400.00 - $188,600.00; Bonus/Equity: Incentive plans, bonuses may be offered; Benefits: Health and welfare and/or other benefits offered

Skills & Requirements

Must-have

  • GCP compliance expertise
  • Lead GCP audits
  • Investigator site audits
  • Vendor audits
  • TMF quality reviews
  • Regulatory requirements (FDA, EMA, ICH-GCP)

Nice-to-have

  • Process improvement experience
  • Project management experience
  • Familiarity with ISO standards
  • Familiarity with EU GDPR

Key Requirements

  • 5–10 years clinical QA experience
  • Medical device experience required
  • Global GCP regulations experience
  • Bachelor’s degree

Work Rights

Not specified

Tailored Resume

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