Quality Systems Associate

il y a 1 semaine

Gent, Flandre, Belgique Johnson & Johnson Temps plein
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, 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 backup process owner for the different Quality System Elements (QSE), like Change Control, Quality Agreements, Site Master File, Global Document Gap Assessments, etc.
  • Develop/build the QSE to support successful Carvykti launch
  • Describe the process in local procedures a/o work instructions
  • Act as site expert on the process
  • Ensure compliance within each of the processes
  • Responsible to provide training
  • Responsible to perform a gap assessment on the process
  • Measuring and managing the process performance in the CAR-T organization
  • Participating in projects related to the process/QSE
  • Act as Trackwise site key user for the CAR-T Europe organization:
  • Attending global user forum meetings
  • Grant and manage Trackwise access, incl periodic review
  • 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

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

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