AssociateDirector,GMPOperationalQuality

**Job Description** **General Summary:** The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams. ### **This On-Site role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210.** ### **1st Shift B1: Wed to Sat 7:00am to 5:30pm** **Key Duties and Responsibilities:** * Leads a team in the Quality Operations organization responsible for internal commercial operations in support of GMP manufacturing and testing activities, including disposition of intermediates, working cell banks and clinical and commercial drug products internally at Vertex manufacturing facilities. * Manages QA On The Floor and QA Walkthrough programs supporting Vertex GMP Facilities. * Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation, consultation, and other support services necessary to maintain and/or improve the quality of Vertex research to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated. * Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP). * Liaise with Vertex clinical functions and external parties including CROs, Vendors and investigator sites to promote high levels of quality and consis