Associate Director, Clinical Quality Operations - (New Haven, CT)

Position can be located in New Haven, CT or Lexington, MA Position description Responsible for: Supporting all phases of Alexion’s clinical development programs to plan, control and improve the quality in accordance with international standards for Good Clinical Practice Partnering with development team(s) to drive quality within the team(s) Principal Responsibilities Develop and implement quality management plan for each assigned program Interpret and provide key metrics to Global Development Team Leader and cross-functional development teammates Support GCP SOP development and serve as quality operations reviewer. Execute risk-based methodologies for the planning and execution of clinical protocols , assuring an ongoing cycle for Plan – Do – Check – Act Manage quality issues including audit reports, quality issues/incidents, and CAPA development, working closely with RDQ audit team and clinical development. Ensure timely implementation and closure of CAPAs.