Job Description - Quality Systems Associate (2406221178W)
Quality Systems Associate CAR-T (M/V/X)
Janssen Pharmaceutica, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Systems Associate CAR-T. The position will be based in Ghent, Belgium.
CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells 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:
1. Act as process owner or back-up process owner for the different Quality System Elements (QSE), like Event Management, Change Control, Supplier Management, etc.
2. Develop/build the QSE to support successful Carvykti launch.
3. Describe the process in local procedures and/or work instructions.
4. Act as site expert on the process.
5. Ensure compliance within each of the processes.
6. Responsible to provide training.
7. Responsible to perform a gap assessment on the process.
8. Measure and manage the process performance in the CAR-T organization.
9. Participate in projects related to the process/QSE.
10. Act as Trackwise/COMET site key user for the CAR-T Europe organization.
11. Attend global user forum meetings.
12. Grant and manage Trackwise/COMET access, including periodic review.
13. Act as SPOC and provide necessary training to users.
14. Perform tasks consistent with the JnJ policies, quality systems, and cGMP requirements.
15. Ensure and maintain a state of inspection readiness.
16. Identify improvements and drive for implementation.
Qualifications:
1. Graduate degree or higher in Science, Bioengineering, pharmacy or related discipline, or equivalent by experience.
2. Knowledge of the pharmaceutical environment, regulatory requirements, and cGMP.
3. Knowledge of the different quality processes and quality systems.
4. Ability to perform investigations and risk analyses.
5. Communicative skills to interact with different business partners (both Dutch and English).
6. A quality mindset.
7. Flexibility to support shifting priorities.
8. Continuous improvement mindset.
Primary Location
Europe/Middle East/Africa - Belgium - East Flanders - Ghent
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