Quality Systems Associate

il y a 1 semaine


Gent, Belgique Johnson & Johnson Temps plein

Established and productive individual contributor, who works under moderate supervision. Administers tasks in support of the Quality Systems department in key quality processes aligned with company standards and high-level goals and objectives. Supports Quality Systems processes; collaborates cross-functionally with key departments to ensure quality standards are communicated throughout the teams and utilized as best practices

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, 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.
- 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/COMET site key user for the CAR-T Europe organization:

- Attending global user forum meetings
- Grant and manage Trackwise/COMET 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**:
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

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.


  • Quality Systems Associate

    il y a 2 semaines


    Gent, Belgique Johnson & Johnson Temps plein

    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, which work by harnessing the power of a...


  • Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a Senior Manager Quality System & Engineering 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...

  • Senior Quality Director

    il y a 2 semaines


    Gent, Flandre, Belgique Mantell Associates Temps plein

    Mantell Associates are partnered with an CDMO organisation in their search for a Director of Quality to join their senior leadership team and build, lead and execute a quality strategy. Director of Quality - Responsibilities: Oversee the organisation's quality planning and execution processes Establish quality strategies to ensure CGMP compliance with...

  • Quality Control Associate

    il y a 2 semaines


    Gent, Belgique Honda Temps plein

    Fix On-Site Ghent, Belgium Posted 30+ days ago Your job as Quality Control Associate As a Quality Control Associate, you and your colleagues in Ghent are responsible for handling market complaints and coordinating stock counts. You get energy from Assessing and processing quality-related complaints so that customers can be resupplied as soon as...

  • Warehouse Associate

    il y a 3 semaines


    Gent, Flandre, Belgique Start People Belgium Temps plein

    Warehouse Associate – Join Our Mission to Transform Healthcare As a Warehouse Associate at Legend Biotech, you're not just moving materials – you're part of a groundbreaking mission to bring life-changing cell therapies to patients who need them most. Precision is Key: Manage inventory with accuracy, ensuring compliance with purchase orders and quality...

  • Director of Quality

    il y a 7 jours


    Gent, Flandre, Belgique Mantell Associates Temps plein

    Mantell Associates are partnered with an CDMO organisation in their search for a Director of Quality to join their senior leadership team and build, lead and execute a quality strategy. Director of Quality - Responsibilities: Oversee the organisation's quality planning and execution processes Establish quality strategies to ensure CGMP compliance with...

  • Quality Assurance Associate

    il y a 1 semaine


    Gent, Flandre, Belgique Perrigo Temps plein

    At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the...

  • Chief Quality Strategist

    il y a 2 semaines


    Gent, Flandre, Belgique Mantell Associates Temps plein

    Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm, partnering with CDMO organisations to find top talent. We are seeking a seasoned Director of Quality to join the senior leadership team and drive quality strategy.Key Responsibilities:Develop and execute quality strategies to ensure CGMP complianceLead Quality teams and...

  • Quality Assurance Lead

    il y a 7 jours


    Gent, Flandre, Belgique Mantell Associates Temps plein

    Mantell Associates, a specialist pharmaceutical and life sciences headhunting firm, is seeking a Director of Quality to join their senior leadership team. This esteemed professional will play a pivotal role in shaping the organisation's quality strategy, ensuring compliance with international regulatory agencies' regulations.The ideal candidate will possess...

  • Glp QA Associate

    il y a 2 semaines


    Gent, Belgique Argenx Temps plein

    To further strengthen our Quality team, we are looking for a motivated QA Associate with a quality mindset; to fulfill a temporary position of 6 months (maternity leave). This role can be filled through consultancy as well. The GLP QA Associate will play a role in further build out of R&D quality infrastructure at argenx in close collaboration with internal...

  • Senior Quality Strategist

    il y a 7 jours


    Gent, Flandre, Belgique Mantell Associates Temps plein

    Mantell Associates, a leading headhunting firm specialising in pharmaceutical and life sciences, seeks a Head of Compliance Management to drive quality excellence. As a key member of the senior leadership team, you will build and lead a Quality organisation, overseeing Quality Control (QC) and Quality Assurance (QA). Your primary focus will be on...


  • Gent, Flandre, Belgique Mantell Associates Temps plein

    Mantell Associates, a specialist pharmaceutical and life sciences recruitment firm, partners with a Contract Development and Manufacturing Organisation (CDMO) to find a Director of Quality to lead their senior leadership team in developing and executing a quality strategy.Key Responsibilities:Oversee the organisation's quality planning and execution...

  • Qs Associate Risk Management

    il y a 1 semaine


    Gent, Belgique Johnson & Johnson Temps plein

    Established and productive individual contributor, who works under moderate supervision. Administers tasks in support of the Quality Systems department in key quality processes aligned with company standards and high-level goals and objectives. Supports Quality Systems processes; collaborates cross-functionally with key departments to ensure quality...

  • Quality System Lead

    il y a 2 semaines


    Gent, Belgique Johnson & Johnson Temps plein

    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...


  • Gent, Belgique Argenx Temps plein

    We are currently looking for a Computer Systems Quality Manager. Key Accountabilities/Responsibilities: - Develop the Computer Systems (CS) Quality strategy - Manage the CS Quality audit program - Create, review and manage the designated validation deliverables such as System Risk Assessments, Validation/Qualification Plan and respective reports - Support...


  • Gent, Belgique Argenx Temps plein

    We are currently looking for a Computer Systems Quality Manager. Key Accountabilities/Responsibilities: - Develop the Computer Systems (CS) Quality strategy - Manage the CS Quality audit program - Create, review and manage the designated validation deliverables such as System Risk Assessments, Validation/Qualification Plan and respective reports - Support...


  • Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a Senior QA Associate for the CAR-T hub in Europe. 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...


  • Gent, Belgique MindCapture Temps plein

    COMPUTER SYSTEM QUALITY MANAGER - Biotech- Ghent & remoteWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success. We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group...

  • QA Associate Car-t- Weekend

    il y a 2 semaines


    Gent, Belgique Johnson & Johnson Temps plein

    Position Title: QA Associate, CAR-T Europe (weekend) Johnson & Johnson (J&J) is recruiting a QA Associate for the CAR-T hub in Europe. 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...

  • Associate Buyer Planner

    il y a 5 jours


    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Position Overview** We are seeking a...