QUALITY SYSTEMS ASSOCIATE
Descripción de la oferta de empleo
The position will be based in 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 building two CAR-T manufacturing centers in the Ghent area (Belgium).
The QC laboratories will be operated from the existing Janssen Beerse site.
The Quality Systems Associate CAR-T is responsible for management and monitoring of the quality systems processes supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Major Responsibilities.
Act as process owner or back-up process owner for the different Quality System Elements (QSE), like Event Management, Change Control, Supplier Management, etc.
o Develop/build the QSE to support successful Carvykti launch o Describe the process in local procedures a/o work instructions o Act as site expert on the process o Ensure compliance within each of the processes o Responsible to provide training o Responsible to perform a gap assessment on the process o Measuring and managing the process performance in the CAR-T organization o Participating in projects related to the process/QSE Act as Trackwise/COMET site key user for the CAR-T Europe organization.
o Attending global user forum meetings o Grant and manage Trackwise/COMET access, incl periodic review o Act as SPOC and provide necessary training to users Perform tasks consistent with the JnJ policies, quality systems and cGMP requirements.
Ensure and maintain a state of inspection readiness Identify improvements and drive for implementation Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Qualifications Qualifications.
Graduate degree or higher in Science, Bioengineering, pharmacy or related discipline, or equal by experience Knowledge of the pharmaceutical environment, regulatory requirements and cGMP Knowledge of the different quality processes and quality systems Knowledge to perform investigations and risk analyses Communicative skills to interact with different business partners (both Dutch and English) You have a quality mindset You are flexible to support shifting priorities You continuously look for improvements
Detalles de la oferta
- Sin especificar
- En toda España
- Sin especificar - Sin especificar
- 20/12/2024
- 20/03/2025
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