What are the responsibilities and job description for the Clinical Quality Manager - Audits position at BioTalent?
Clinical Quality Manager – Clinical Trial Audits
We are looking for a clinical quality professional with hands-on GCP audit experience who can independently assess trials, identify risks, and strengthen compliance across global studies.
What You’ll Do
- Lead and conduct GCP audits across investigator sites, CROs, vendors, and internal processes
- Drive inspection readiness and support regulatory audits (e.g., FDA, notified bodies)
- Identify quality risks and manage deviations, nonconformances, and CAPA
- Perform quality review of key clinical documents to ensure compliance with GCP and regulatory standards
- Serve as an independent clinical quality authority, partnering with cross-functional teams
- Strengthen QMS, SOPs, and audit frameworks to improve clinical trial quality and consistency
What We’re Looking For
- 6–8 years of experience in clinical trials within the medical device industry
- Strong background in Clinical Quality / QA (not solely clinical operations)
- Proven experience conducting GCP audits is required
- Deep knowledge of GCP, ICH guidelines, and medical device regulatory requirements
- Hands-on experience with CAPA, audit findings, and inspection readiness
Preferred
- Experience in diagnostics, or oncology
- Experience with IDE or medical device clinical trial audits
Why This Role
This is a high-impact opportunity to take ownership of clinical audit and quality oversight across innovative studies.
Salary : $165,000 - $185,000