Operations Manager

2 semanas atrás

Caicó, Rio Grande do Norte, Brasil beBeeOperational Tempo inteiro R$118.400 - R$156.000
Tissue Operations Manager

Develop innovative solutions to streamline apheresis and treatment centre operations for CAR-T-cell therapies.

This role oversees onboarding, performance management, and technical site assessments for assigned regions.

Key Responsibilities:

  • Tissue Operations Management: Develop relationships with Apheresis, Cell Lab, and Treatment Centre staff for assigned regions.
  • Apheresis Collection Planning: Collaborate with Clinical and Commercial CAR-T teams to establish apheresis collection footprints for clinical trial site plans.
  • Onboarding Coordination: Coordinate internal teams and collection site staff for successful onboarding activities and timely collections.
  • Collections On-Boarding Status: Communicate collection site on-boarding status and develop mitigation plans for delayed timelines.
  • Techical Site Assessments: Perform technical site assessments, train collection centre staff, and attend site audits as required.
  • Quality Systems Support: Provide Quality Systems support through deviation activities and impact/investigation assessments.
  • Vendor Performance Monitoring: Monitor and assess vendor performance and capacity after site launch.
  • Process Changes Rollout: Manage process changes rollout and collect VOC/VOB feedback for continuous operations improvement.
  • Data Entry: Collect and enter data into electronic data management systems.
Required Skills and Qualifications
  • Apheresis Operations Experience: Experience in Apheresis Operations Management, QA Operations, GMP production, or other relevant operational areas.
  • Regulated Environment Knowledge: Breadth of experience in regulated environments, understanding of HTA, and knowledge of applicable regulations.
  • Problem-Solving Ability: Ability to rapidly solve problems and deal with organizational complexity.
  • Medical and Scientific Knowledge: Medical, scientific, and clinical knowledge.

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