Sr. Clinical Qa Auditor

IQVIA UK

Base: $75,400.00 - $188,600.00; bonus/equity: not ...
Fully remote
Gcp compliance expertise
Clinical trial auditing
Regulatory requirements (fda, ema, ich-gcp)
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 designing and leading mock regulatory inspections.
  • 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 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: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • GCP compliance expertise
  • Clinical trial auditing
  • Regulatory requirements (FDA, EMA, ICH-GCP)
  • TMF quality reviews
  • Quality improvement initiatives

Nice-to-have

  • Strategic input on quality systems
  • Process improvement and project management
  • Familiarity with ISO standards and EU GDPR

Key Requirements

  • 5-10 years of experience
  • Medical device experience required
  • Bachelor’s degree

Work Rights

Not specified

Tailored Resume

Cover Letter