Director, CDx Quality & Regulatory QMS

A biotechnology firm in Redmond, WA is seeking a Director, Head of Quality Management System to lead quality management for IHC-based Companion Diagnostics. This role involves ensuring compliance with GMP and FDA regulations, overseeing quality documentation, and leading a team to maintain readiness for FDA inspections. Candidates should possess extensive experience in quality management within the medical device sector, making significant contributions to regulatory success and product quality.
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