Senior Quality Auditor
$15,000–$20,000 year
RemoteUnited States
Job Summary
Schedule, conduct, and document external GCP audits for investigator sites, trial master files, data management, safety reporting, and vendors. Lead for-cause audits addressing suspected critical findings, fraud, or misconduct involving regulatory violations and controlled substances. Write and issue audit reports adhering to standard company formats and timelines while maintaining accurate documentation of all QA activities. Requires extensive experience as a lead auditor, deep GCP knowledge, and the ability to travel up to 75%. Collaborate across clinical and commercial disciplines to guide premarket development through post-market strategy for biopharmaceutical therapies.
Required Qualifications
- extensive experience as the lead or primary auditor conducting external clinical trial audits
- deep understanding of CRO auditing
- excellent communication skills
- Bachelor's degree in the science/health care field or equivalent combined education and experience
- Extensive experience in clinical quality assurance auditing and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc.)
- Strong knowledge of all applicable Good Clinical Practice (GCP) regulations and guidelines
- The ability to travel up to 75%
Desired Qualifications
- Knowledge of medical terminology
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
- Strong organizational, presentation, documentation and interpersonal skills with diverse cultures
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