QA Car-t Qualification Lead Emea

il y a 1 semaine

Gent, Flandre, Belgique Johnson & Johnson Temps plein
Johnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead Engineer for the CAR-T hub in Europe.

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, J&J IM is starting up two CAR-T manufacturing centers in the Ghent area (Belgium).

The QC laboratories will be operated from the existing Janssen Beerse site.

The CAR-T QA C&Q Lead Engineer is part of the CAR-T QA Qualification Team in Ghent.

He/She will be responsible for review and approval of qualification and requalification activities, related to Facilities and Utilities (F&U) and Process Equipment at the Janssen/Legend Biotech facilities in Ghent.


Responsibilities:

  • Responsible for managing a team of CAR-T QA Qualification Engineers and providing QA oversight for qualification activities.
  • Will work closely together with the MAM (make asset management) and E&PS department and guard the qualification status of critical production assets by ensuring that all system critical aspects related to facilities & utilities, product and process requirements are identified; qualified and controlled by a mitigation plan and ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented
  • Will work closely together with the manufacturing department to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented
  • Will build a strong connect with different quality organizations (e.g. external quality)
  • Will manage the compliance status of critical production (make) assets by means of review and approval of procedures e.g. calibration rationales, calibration master forms and completed calibration records, master data setup, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviews
  • Participates in the preparation for regulatory and customer inspections and act as a spokesperson for QA qualification
  • Approves qualification documents (change controls, master documents, protocols, reports, rationales, SOP's, URS, IA, QSR, etc.) including discrepancies/events/nonconforming situations and related corrective actions (correction, CPA) occurring during execution of qualification activities.
  • Participates in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert.

Qualifications:

- master's degree in engineering with chemistry or analytical background or in pharmaceutical sciences
- awareness of quality; have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products and you see it as a challenge to defend our strategy and documents towards health authority inspections.
- affinity with computerized systems, System parameter configurations and data management in critical production assets
- thorough knowledge of Dutch and English, both orally and in writing

  • Strong analytical thinking, risk assessment and communication skills
  • Collaboration and teaming skills

What is in it for you?


You will be part of an enthusiastic team that has a strong quality focus on technology, qualification, automation, and continuous improvement.

Employees are very valuable to our organization and development is a daily responsibility.

Through on the job training, e-learning, implementation of various projects and programs we ensure personal growth by focusing on your talents.

We offer you a contract of indefinite duration with an attractive salary package including extra-legal benefits such as meal vouchers, additional pension plan and hospitalization insurance.


Application Process

Equal Opportunity Statement
The employers of the Johnson & Johnson family value diversity and inclusion. We are committed to building diverse teams that reflect both the patients and the partners we support.

We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential.

  • QA Car-t Qualification Lead Emea

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    CAR-T QA C&Q EngineerThe Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a CAR-T QA C&Q Engineer for the CAR-T hub in Europe.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...

  • Senior QA/qp Manager Car T Emea

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior QA/QP Manager for the CAR-T hub in Europe. The position will be mainly 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...

  • Sr QA Associate Car-t Emea

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Flexible work practices, award-winning benefits This position will be based in Ghent, Belgium.Change lives for the better.THE OPPORTUNITYHow you can help.Johnson & Johnson (J&J) is recruiting a Sr QA Associate, QA Operations Lead 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...

  • QA/qp Operation Director Car T

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior QA/QP Manager for the CAR-T hub in Europe.- 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'...

  • QA Project/operation Manager Mes Car-t Emea

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Flexible work practices, award-winning benefits This position will be based in Ghent, Belgium.Change lives for the better.THE OPPORTUNITYHow you can help.The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior QA Project Engineer for the CAR-T hub in Europe. The position will be based in Ghent...

  • Senior QA Associate Car-t

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is op zoek naar een Senior QA Associate aan voor het CAR-T-hub in Europa. De functie zal gevestigd zijn in Gent, België.CAR-T (chimeric antigen receptor T-cell therapy) is een innovatieve aanpak om kankercellen te elimineren, waarbij gebruik wordt gemaakt van de kracht van het eigen immuunsysteem van de patiënt. Ze worden gecreëerd...

  • QA/qp Support Lead, Car-t Europe

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a QA/QP Support Lead 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 blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells....

  • Senior QA Associate Release Car-t Europe

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a Sr 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 are...

  • QA Lab Associate Ipl Car-t

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab 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...

  • QA Project Lead

    il y a 1 semaine

    Gent, Flandre, Belgique 3W Select Interim Management Temps plein

    QA Project Lead:Senior Project/Program Management IArea of Ghent I40 uurOur Client is a joint venture between 2 major players in the pharmaceutical sector. They are currently looking for a QA Project Lead for a highly time-driven strategic project.Function descriptionManage the strategic time-driven project & all stakeholdersCreate and install metrics (Right...

  • QA Lead Investigations

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a QA Operations Lead Investigations, 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 blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the...

  • QA Lab Associate Car-t Ipl

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab 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...

  • Quality System Lead

    il y a 1 semaine

    Gent, Flandre, 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...

  • Commissioning, Qualification

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Are you passionate about improving the lives of cancer patients? We work on the most sophisticated treatment options available today 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...

  • QA Lab and Data Integrity Management Car-t

    il y a 1 semaine

    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab and Data Integrity associate for the CAR-T hub in Europe. The position will be based in Gent Belgium.CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient's own immune...

  • QA Consultant

    il y a 1 semaine

    Gent, Flandre, Belgique Capgemini Temps plein

    We're supporting one of our biggest clients in Belgium in the set-up of two brand-new manufacturing facilities for the revolutionary new CAR-T cell therapy used to treat blood cancers. Our QA team of commissioning & qualification consultants is responsible for ensuring compliance of qualification activities through review and approval of system qualification...

  • QA Consultant

    il y a 1 semaine

    Gent, Flandre, Belgique Capgemini Temps plein

    We're supporting one of our biggest clients in Belgium in the set-up of two brand-new manufacturing facilities for the revolutionary new CAR-T cell therapy used to treat blood cancers. Our QA team of commissioning & qualification consultants is responsible for ensuring compliance of qualification activities through review and approval of system qualification...

  • EMEA BIS Operations lead

    il y a 1 semaine

    Gent, Flandre, Belgique Argenx Temps plein

    For the expansion of our Business Information Systems (BIS) team, argenx is looking for an EMEA (Europe, Middle East and Africa) BIS Operations lead - Commercial and Medical.The Lead will be a key member of the BIS Commercial and Medical affairs team and will act as the Digital, Process and Technology business partner for the EMEA Commercial and Medical...

  • 18588 - Project Manager CAR-T J&J

    il y a 1 mois

    Gent, Flandre, Belgique Randstad Temps plein

    CAR-T is an innovative treatment, which uses the power of the patient's own immune system. A patient's T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.Janssen Biotech, Inc. entered into a global...

  • Emea Commercial and Medical Affairs Operations Lead

    il y a 1 semaine

    Gent, Flandre, Belgique Argenx Temps plein

    For the expansion of our Business Information Systems (BIS) team, argenx is looking for an EMEA (Europe, Middle East and Africa) Commercial and Medical Affairs Operations Lead.The Lead will be a key member of the BIS Commercial and Medical affairs team and will act as the Digital, Process and Technology business partner for the EMEA Commercial and Medical...