This position reports to the Site Head of Quality, and the person filling this role is responsible for partnering with functional stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initaitives, Operations, functional support organizations, and execution of GMP activities at the Rockville site. This position interacts regularly with key clients as well as interfaces with regulatory agencies during inspections. This position is responsible for overseeing all quality operations functions, including execution of environmental monitoring, sterility assurance, routine QC testing and deliver to stability testing, and the overall oversight and operation of the Quality Testing Lab. This position will also oversee timely batch lot disposition, timely investigation and CAPA related to deviations. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new production processes.