Quality Assurance Manager

The Manager, Quality Assurance role will support manufacturing operations, late‑stage clinical development, and commercial readiness. This role plays a critical part in ensuring compliance with FDA regulations, cGMPs, and internal Quality Systems while supporting Phase 3 clinical trials for CDX‑0159, preparation and submission of the Biologics License Application (BLA), and subsequent commercial activities. The ideal candidate brings strong regulatory judgment, hands‑on QA expertise, and a proactive leadership mindset focused on inspection readiness, compliance excellence, and continuous improvement.