Sr. Clinical Qa Auditor

MCRA

Base: $75,400.00 - $188,600.00; bonus/equity: not ...
Fully remote
Gcp compliance expertise
Clinical trial quality assurance
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 5-10 years of experience in clinical quality assurance, auditing, or clinical operations within a CRO, pharma, or biotech environment, with medical device experience required.

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: Not specified; Benefits: Range of health and welfare and/or other benefits

Skills & Requirements

Must-have

  • GCP compliance expertise
  • Clinical trial quality assurance
  • Investigator site audits
  • Vendor audits
  • Sponsor audits
  • TMF quality reviews

Nice-to-have

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

Key Requirements

  • Bachelor’s degree
  • 5–10 years of experience
  • Medical device experience required
  • Global GCP regulations experience
  • Proficient in MS Office applications

Work Rights

Not specified

Tailored Resume

Cover Letter