Senior Manager Patient Operations Apheresis Europe
hace 2 semanas
As a Senior Manager Patient Operations Apheresis Europe, you will be responsible for managing onboarding and ongoing performance of Apheresis Centers used for Celgene/BMS Clinical and Commercial Antigen Receptor (CAR) T cell Therapies in their assigned region. You will work cross-functionally with a large set of stakeholders within the Cell Therapy Franchise, at local, regional, and global levels.
Duties and Responsibilities:
Onboard and manage Apheresis sites involved in clinical and commercial Chimeric Antigen Receptor (CAR) T-cell Therapies as per launch plans and established processes, in collaboration with internal clinical and commercial teams for Spain and other markets as needed.
Develop and foster relationships with Apheresis Center Staff for assigned region.Collect VOC (Voice of Customer) and VOB (Voice of Business) feedback used for continuous operations improvement.
Comply with applicable SOP's and regulations.
Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers, as well as change controls and GxP documentation, as required.
Closely work and collaborate with Scheduling and Cell Therapy Operations, Quality Assurance, Supply Chain, Clinical & Commercial, Information Technology, Project Management teams and other internal business partners such as local affiliates.
Manage and collaborate on local, regional, and global projects, as assigned.Manage rollout of process changes internally and with assigned sites, as applicable.
Ensure data is accurately captured and consistent using the Information Systems and tools deployed within the organization.
Develop, monitor, and roll out KPIs and reporting tools.
Requirements:
Required minimum 5 years of experience in a regulated environment either hospital or pharmaceutical/biotech industry.
Experience working in Cell Therapy, Apheresis or Stem Cell Transplant programs
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