Quality System Lead - Gent, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Gent, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

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 Companywide 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 68 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.
Good written and verbal communication skills are required.