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Quality System Lead - CAR T

Auris Health

Auris Health

Quality Assurance
Ghent, Belgium
Posted on Tuesday, August 29, 2023
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Description

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Quality System Lead for the CAR-T hub in Europe. The position will be based in Beerse or Ghent Belgium.
CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
To support the CAR-T program in EMEA, Janssen is starting up two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.
The Quality System Lead, CAR-T Europe is accountable for the implementation and maintenance of the overall EMEA CAR-T quality system management plan.

Major Responsibilities:
- Implementation and maintenance of the CAR T quality management system in alignment with all applicable regulations and Corporate J&J standards.
- Establish and maintain effective working relationships with business and quality functions of Janssen and our collaboration partner Legend Biotech to ensure compliance with all quality system requirements.
- Collaborate with Process Development teams and Operations to successfully transfer CAR-T process to cGMP facility to manufacture products.
- Provides oversight and maintenance of applicable Quality Agreements.
- Represent the site for establishment and implementation of Company-wide quality policies, strategies and practices.
- Support together with Site QA Head, regulatory health authority inspections.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. 
- Set up maintain key performance quality indicators. Summarizes and present results to senior management.

Qualifications

- A minimum of a Bachelor Degree in Engineering, Science or equivalent technical discipline is required.
- A minimum of 6-8 years of experience in Quality Assurance related to manufacturing is required.
- A minimum of 2 years of experience with quality support in clinical or commercial manufacture or NPI is preferred. Experience with Quality support in clinical manufacture or NPI is preferred.
- Experience working with Quality systems is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products as well as knowledge of Good Tissue Practices.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.