AstraZeneca

  • Gaithersburg, MD, United States
AstraZeneca Gaithersburg, MD
Job Responsibilities Perform audit and site qualifications of Apheresis, Cryopreservation, and infusion centers. qualification and audit of cell supplying vendors. Perform qualification and audit of cell supplying vendors. Perform audit and site qualifications of Apheresis, Cryopreservation, and infusion centers. qualification and audit of cell supplying vendors Provide Quality oversight to Apheresis, Cryopreservation and infusion centers. Author and negotiate quality agreements Participate and provide support to deviations, CAPAs, OOS, change controls and product complaints involving Apheresis and Infusion centers and cell supplying vendors. Liaison between Manufacturing site Quality and Apheresis/Cryopreservation centers on quality related issues. Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies. Audit readiness support for regulatory inspections queries...

AstraZeneca Boston, MA
Associate Director Strategic Planning & Execution, US Medical Affairs is responsible for the execution of strategic initiatives within the US Medical Affairs organization, partnering with Therapeutic Area Leadership teams and cross‑functionally to align projects with the organization’s overall strategic goals. The role analyses, resolves, and communicates on key strategic programs, enabling US Medical Affairs Leadership to make informed decisions that contribute to the function’s success. Project management techniques are applied to ensure scope, schedule, and budget goals are met. Responsibilities Strategic Partnership: Develop annual enterprise strategy for assigned TA and/or Function and ensure effective, efficient, and equitable delivery of key strategic programs and operational activities. Oversee business progress against performance targets through outcomes and metrics tracking/reporting. Highlight and communicate US Medical impact and effectiveness throughout all...