Senior Manager Pdp Program Lead

Há 2 dias

Criciúma, Santa Catarina, Brasil beBeeDevelopment Tempo inteiro R$140.000 - R$170.000
Job Title: Senior Manager Pdp Development

We are seeking a skilled and experienced professional to fill the role of Senior Manager Pdp Development. The ideal candidate will have a strong background in development and management, with a proven track record of success in leading teams and driving projects forward.

  • The Senior Manager Pdp Development will be responsible for managing the development and implementation of programs, including Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas.
  • The successful candidate will have experience working in regulated (GxP) environments, understanding of HTA (either hospital or pharmaceutical/biopharmaceutical company).
  • They will also have experience working with critical raw material suppliers or contract manufacturing organizations.
  • An undergraduate degree in a related science or nursing is required, with an advanced degree in a related science or nursing being preferred.
  • The ideal candidate will be fluent in English and Portuguese, and possess excellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple cultures.
Key Responsibilities:

The Senior Manager Pdp Development will be accountable for the following key responsibilities:

  • Developing and fostering relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
  • Working with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support the clinical trial site plans for assigned region.
  • 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 the required timelines.
  • Communicating collection site onboarding status to Clinical teams and developing mitigation plans for any delayed timelines.
  • Performing technical site assessments and training collection center 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 centers.
  • 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 and 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 and representing the department on cross-functional project teams as requested.
Benefits:

The successful candidate will receive a competitive salary and benefits package, including opportunities for career growth and development.

Other Information:

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

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