Clinical Quality Manager

A company is looking for a Clinical Quality Manager (CQM), Principal Manager - Quality Events.



Key Responsibilities

Lead cross-functional teams in investigation, root cause analysis (RCA), and CAPA development for Quality Events
Manage visibility and awareness of deviations, issues, or deficiencies and escalate to management as needed
Liaise with internal and external parties to ensure quality and consistency across clinical programs



Required Qualifications

7 years of experience in the biopharmaceutical industry or equivalent education and experience
Strong end-to-end clinical trial execution experience
Familiarity with Veeva QMS system
In-depth understanding of GCP, ICH guidelines, and CFR
Experience managing clinical quality activities and knowledge of clinical operations