Director of Operations

Há 2 dias

Criciúma, Santa Catarina, Brasil beBeeManager Tempo inteiro R$70.000 - R$110.000

Senior Manager Pdp Development is a high-profile position that oversees release management activities in support of clinical CAR-T therapies. The role involves coordinating with cross-functional teams to ensure timely delivery across regulatory and quality frameworks. This position requires strong leadership skills, including the ability to manage contract employees, foster relationships with Apheresis, Cell Lab, and Treatment Centre staff, and communicate effectively across all levels within the organization.

The successful candidate will have experience in Apheresis Operations Management, QA Operations, GMP production, GTP, or other relevant operational areas. They should have a breadth of experience in regulated environments, understanding of HTA (Hospital or Pharmaceutical/Biopharmaceutical Company), and be fluent in English and Portuguese. Additionally, they should possess excellent interpersonal and presentation skills, medical, scientific, and clinical knowledge, and knowledge of applicable regulations and standards.

Responsibilities include:

  • Developing and fostering relationships with Apheresis, Cell Lab, and Treatment Centre staff for assigned regions.
  • Working with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support clinical trial site plans for assigned regions.
  • Coordinating with internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to perform collections within required timelines.
  • Communicating collection site onboarding status to Clinical teams and developing and executing mitigation plans for any delayed timelines.
  • Performing technical site assessments and training collection centre staff on collection requirements and attending site audits as required. Providing Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centres.
  • Working with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
  • Managing rollout of process changes to assigned sites. Collecting VOC (Voice of Customer) and VOB (Voice of Business) feedback used for continuous operations improvement.
  • Collecting and entering data into electronic data management systems. Representing the department on cross-functional project teams, as requested.

If you are a motivated and experienced professional looking for a challenging opportunity, please apply. Harry Henson will be in touch to discuss your application further.

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