Director of Site Operations

Há 13 horas

Brasil beBeeOperations Tempo inteiro R$120.000 - R$160.000
Senior Operations Manager

This role is responsible for managing onboarding and ongoing performance of Apheresis and Treatment Centres used for CAR T-cell Therapies. The Senior Manager - Tissue Operations will serve as the technical operations single point of contact for Apheresis and Treatment Centres located within the designated region, working closely 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 the required timelines.

Key Responsibilities:
  • Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
  • Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support the clinical trial site plans for assigned region.
  • Coordinate 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 the required timelines.
  • Communicate collection site on-boarding status to Clinical teams and develop and execute mitigation plans for any delayed timelines.
  • Perform technical site assessments and train collection center staff on collection requirements and attend site audits as required. Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
  • Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
  • Manage rollout of process changes to assigned sites. Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement.
  • Collect and enter data into electronic data management systems. Represent the department on cross-functional project teams, as requested.
  • Comply with applicable SOP's and regulations.
Required Skills and Qualifications:
  • Bachelor's degree in related science or nursing.
  • Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas.
  • Ability to rapidly solve problems and deal with organizational complexity.
  • High attention to detail skills.
  • Excellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple cultures.
Benefits:

The ideal candidate will have excellent communication and interpersonal skills, with the ability to work effectively in a team environment.

Others:

Please apply here and Harry Henson will be in touch to discuss your application further.

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