Senior Manager

Há 3 dias

Porto Alegre, Rio Grande do Sul, Brasil beBeeOperations Tempo inteiro US$90.000 - US$122.000
Job Overview:

We are seeking a highly skilled professional to oversee the onboarding and ongoing performance of Apheresis and Treatment Centres for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies. This role serves as the technical operations single point of contact for designated regions, managing contract employees when necessary.

Key Responsibilities:
  • Develop and foster relationships with Apheresis, Cell Lab, and Treatment Centre Staff in assigned regions.
  • Collaborate with Clinical and Commercial CAR-T teams to establish apheresis collection footprints for assigned regions.
  • Coordinate site onboarding activities with internal teams and staff to ensure timely completion.
  • Communicate site status to Clinical teams and develop mitigation plans for delayed timelines.
  • Perform technical site assessments, train centre staff, and attend audits as required.
  • Provide Quality Systems support by participating in deviation activities and assessments.
  • Work with Quality Assurance to monitor vendor performance and capacity.
  • Manage process changes at assigned sites and collect VOC/VOB feedback for continuous improvement.
  • Represent the department on cross-functional project teams and comply with applicable SOPs and regulations.
Requirements:
  • Bachelor's degree in a relevant field such as Science or Nursing.
  • Advanced degree preferred.
  • Fluency in English is mandatory, while Portuguese language skills are desirable.
Essential Skills:
  • Experience in Apheresis Operations Management, QA Operations, GMP production, or other relevant areas.
  • Breadth of experience in regulated environments and HTA knowledge.
  • Proven team player with successful delivery of process improvements in qualification, training, and management of external cell procurement suppliers.
  • Contract management expertise with external apheresis providers.
Detailed Information:

This position requires 75% regional travel. The ideal candidate will possess strong interpersonal skills, medical, scientific, and clinical knowledge.

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