Senior Operations Specialist

Há 6 horas

Salvador, Bahia, Brasil beBeeOperations Tempo inteiro R$94.400 - R$133.400

RBW Consulting seeks a highly skilled Senior Operations Specialist to manage the onboarding and performance of Apheresis and Treatment Centres for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

About the Role

This senior-level position requires expertise in contract employee management, technical operations, and relationship development with cross-functional teams.

The ideal candidate will possess exceptional problem-solving skills, organizational complexity management, and the ability to prioritize tasks with urgency based on criticality.

Key Responsibilities
  • Develop strong relationships with Apheresis, Cell Lab, and Treatment Centre Staff.
  • Collaborate with Clinical and Commercial CAR-T teams to establish apheresis collection footprints.
  • Coordinate internal team and collection site staff to ensure successful onboarding activities and timely site preparation.
  • Communicate on-boarding status to Clinical teams and develop mitigation plans for delayed timelines.
  • Perform technical site assessments, train collection centre staff, and attend site audits as required.
  • Provide Quality Systems support by participating in deviation activities and impact/investigation assessments.
  • Work with Quality Assurance and internal business partners to monitor vendor performance and capacity.
  • Manage process changes rollout to assigned sites.
  • Collect VOC and VOB feedback for continuous operations improvement.
Required Skills and Qualifications
  • Apheresis Operations Management, QA Operations, GMP production, or relevant operational areas.
  • Regulated environment experience, understanding of HTA (hospital or pharmaceutical/biopharmaceutical company).
  • Apheresis, Cellular Therapy, or Stem Cell Transplant programs knowledge.
  • Critical raw material suppliers or contract manufacturing organizations management.
  • Team-based environment experience.
  • Process improvements in qualification, training, and management of external cell procurement suppliers.
Benefits

This role offers a unique opportunity to work in a rapidly evolving field, with a focus on delivering high-quality services and products. The ideal candidate will be motivated by the prospect of making a meaningful contribution to the success of our organization.

We offer a competitive compensation package, including benefits and opportunities for professional growth and development.

This is a remote-based position, with up to 75% regional travel required.

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