Senior Operations Manager

Há 2 dias

Brasil beBeeOperations Tempo inteiro
Job Opportunity: Senior Operations Manager

The ideal candidate will be responsible for overseeing the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

About this Role:
  • This role involves developing and maintaining relationships with Apheresis, Cell Lab and Treatment Centre Staff to ensure seamless operations.
  • The Senior Operations Manager will work closely with Clinical and Commercial CAR-T teams to establish apheresis collection footprints in support of clinical trial site plans.
  • Critical responsibilities include coordinating internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed within required timelines.
  • The selected candidate will communicate collection site onboarding status to Clinical teams and develop mitigation plans for any delayed timelines.

Key Responsibilities:

  • Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned regions.
  • Work with Clinical and Commercial CAR-T teams to establish apheresis collection footprints in support of clinical trial site plans.
  • Coordinate internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed within required timelines.
  • Communicate collection site onboarding status to Clinical teams and develop mitigation plans for any delayed timelines.
  • Perform technical site assessments and train collection center staff on collection requirements.
  • Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
  • Manage rollout of process changes to assigned sites.
  • Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement.
  • Represent the department on cross-functional project teams as requested.
Requirements:
  • Breadth of experience in regulated (GxP) environments, understanding of HTA (either hospital or pharmaceutical/biopharmaceutical company).
  • Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs preferred.
  • Has successfully worked in a team-based environment.
  • Experience in delivering process improvements, ideally in processes for qualification, training, and management of external cell procurement suppliers.
  • Undergraduate degree in related science or nursing required.
  • Fluency in English and Portuguese is essential.

What We Offer:

  • Rapidly solve problems and deal with organizational complexity.
  • Prioritize and complete work with sense of urgency based on criticality.
  • Medical, scientific and clinical knowledge.
  • Knowledge of applicable regulations and standards.
  • High attention to detail skills.
  • High organization skills with ability to multi-task several tasks in parallel.

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