The Director, CMC Quality will provide strategic leadership for quality oversight across the development and lifecycle management of cell therapy programs. This role involves managing QC operations, ensuring regulatory compliance, and driving risk-based control strategies in partnership with cross-functional teams.
The CRA will conduct remote and on-site monitoring visits to ensure clinical trial data accuracy and compliance with GCP and protocols. They will collaborate with internal teams and CRO partners to manage site performance and support the execution of CAR T clinical trials.
Lead the global regulatory CMC strategy and operational submissions for clinical-stage cell therapy programs. This includes authoring Module 3 content and managing interactions with global health authorities to ensure product quality and safety.
