Senior Director, IDMO Site Quality

We are seeking a highly motivated Senior Director of IDMO Site Quality who will play a critical role in the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.

 

This individual will lead the Quality organization (QA/QC) and partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirements by leveraging and expanding the site Quality Management Systems (QMS) and ensuring regulatory compliance. This individual will provide strategic leadership to ensure alignment with customer needs and business strategies. As such, the role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups to ensure robust production, testing, and release of product to patients.

 

This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Operations, MS&T, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, HS&E, and Finance.

 

The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.