Quality Systems Associate

Johnson & Johnson

4.2

(92)

Ghent, Belgium

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.
  • #2406221178W

    Position summary

    nical 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

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.