Clinical Quality Manager - Audits

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.