Operations Director

Há 2 dias

Belo Horizonte, Minas Gerais, Brasil beBeeCarer Tempo inteiro
Operational Management Lead

We are seeking an experienced Operational Management Lead to manage onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

The role will serve as the technical operations single point of contact for Apheresis and Treatment Centres within designated regions.

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 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 required timelines.
  • Communicate collection site on-boarding status to Clinical teams and develop mitigation plans for delayed timelines.
  • Perform technical site assessments and train collection centre 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 centres.
  • 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 and VOB feedback for continuous operations improvement.
  • Collect and enter data into electronic data management systems. Represent the department on cross-functional project teams, as requested.

Demonstrated Skills and Competencies:

Experience in Apheresis Operations Management, QA Operations, GMP production, or other relevant operational areas.

Breadth of experience in regulated environments, understanding of HTA either hospital or pharmaceutical/biopharmaceutical company.

Excellent interpersonal and presentation skills to communicate effectively across all levels within the organisation and multiple cultures.

Ability to rapidly solve problems and deal with organisational complexity.

Ability to prioritise and complete work with sense of urgency based on criticality.

High attention to detail skills.

High organisation skills with ability to multi-task several tasks in parallel.

Critical thinking and problem-solving skills.

Excellent analytical skills.

Results-driven individual with strong communication and leadership skills.

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