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Clinical Quality Manager - Audits

Job

BioTalent

Chelsea, MA (In Person)

Full-Time

Posted 1 week ago (Updated 3 days ago) • Actively hiring

Expires 7/13/2026

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Job Description

Clinical Quality Manager - Audits at BioTalent Clinical Quality Manager - Audits at BioTalent in Chelsea, Massachusetts Posted in 2 days ago.
Type:
full-time
Job Description:
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.