Executive Director, CMC Quality Assurance

The Executive Director, CMC Quality Assurance will be responsible for leading and building a comprehensive Quality Assurance (QA) team to support the development, manufacturing, and regulatory approval of all Dianthus products. Reporting to the VP, Head of Quality, you will execute and oversee QA processes that assure global GMP and GLP compliance as applicable to the regions where Dianthus clinical studies are executed. You will work closely with your peers in the Quality Unit, our Technical Operations and Supply Chain teams and other cross-functional teams to support biologic and device-specific global regulatory requirements are met. Your role will be integral in assuring Dianthus is inspection-ready at all times. Experience with combination product drug delivery systems and expertise in leading QA efforts is necessary to be successful in this role. As Dianthus is a virtual company, we rely on our multitude of critical vendors for flawless GMP and GLP execution on our behalf on all activities in our Investigational Product Supply Chain (e.g. drug/device development through finished product shipment to our clinical sites). The Executive Director, QA must possess experience and skill collaborating and influencing CDMO’s, laboratory, and pack/label vendors in a positive way.