Senior Manager of CMC Quality Assurance

We are seeking an experienced Senior Manager of CMC Quality Assurance to spearhead the quality assurance initiatives for our pioneering curative stem-cell therapies. This role involves establishing and refining the quality assurance processes for the development of HSPC based, HDR (homology directed repair) therapies.

What You Will Do:

• Lead cGMP quality assurance activities for all relevant manufacturing operations, including product disposition via batch record and certificate of analysis (COA) review, in collaboration with our Contract Manufacturing Organization (CMO).
• Develop, implement and manage a comprehensive electronic Quality Management System (eQMS) to support pre-clinical and clinical manufacturing and clinical operations, including development, review and approval of internal documentation, such as Standard Operating Procedures (SOPs) and methods.
• Support development and implementation of Clinical Affairs...