![Johnson & Johnson](https://media.trabajo.org/img/noimg.jpg)
Senior QA/qp Manager Car T Emea
il y a 3 semaines
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 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 Senior QA/QP Manager is part of the Quality Leadership Team. He/She will lead the QA/QP team that is responsible of both investigational medicinal and commercial CAR-T products out of the Janssen/Legend Biotech facilities in Ghent.
The Senior QA/QP Manager will provide QA input and decisions based upon a combination of cGMP knowledge (expertise in advanced therapy medicinal Products (ATMP) regulations) and expertise of cell and gene therapy processes and/or process technologies to establish the appropriate holistic Process Control Strategy.
**Major Responsibilities**:
- Lead the QA/QP team that is responsible of both investigational medicinal and commercial CAR-T products out of the Janssen/Legend Biotech
facilities in Ghent- Act as an expert resource in assessing and maintaining quality and compliance levels
- Continuously challenge the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organizational and quality performance
- Provide QA expertise in the Technical Operations discussions based upon a combination of intensive GMP knowledge of ATMP’s, knowledge in aseptic techniques and extensive process knowledge of cell and gene therapy products
- Establish and maintain effective working relationships with the different business partner and Legend Biotech to ensure alignment of objectives and deliverables
- Ensure quality oversight of the operational activities by documented QA approval of GMP documentation and support in the different quality review meetings
- Ensure and manage the implementation and execution of the different quality system processes
- Support the operational and QA departments by providing coaching and/or training
- Ensure that deviations/complaints are timely and properly investigated. Deviations/complaints with potential impact on patients and/or product supply are properly escalated
- Ensure that adequate CAPA’s are defined for investigations with potential quality impact
- Act as key spokesperson for Health Authorities
**Qualifications**:
**Experience and Skills**:
Education/Experience: Master Degree in Pharmaceutical Science, Bio
- Engineering, or equivalent technical discipline is required. A minimum of 8-10 years within the biotechnological pharmaceutical industry with relevant experience related to manufacturing of Cell and Gene Products is required. A Certified Industrial Pharmacist is an advantage.**Key Capabilities, Knowledge, and Skills**:
- Strong People leader skills
- Strong analytical thinking and decision-making skills.
- In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes.
- Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation related to clinical trials and cGMP regulations related to manufacturing of cell therapy products as well as knowledge of Good Tissue Practices.
- Excellent verbal and written communication skills to negotiate and communicate with external and internal customer and partners.
- Experience working with Quality systems is required.
- Experience with aseptic processing and technics is required.
- Highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
-
Senior QA/qp Manager Car T Emea
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinThe 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...
-
QA/qp Operation Director Car T
il y a 3 semaines
Gent, Belgique Johnson & Johnson Temps pleinThe 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...
-
QA/qp Operation Director Car T
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinThe 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'...
-
Sr. QA Associate Car-t Emea
il y a 2 semaines
Gent, Belgique Johnson & Johnson Temps pleinJohnson & 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...
-
Senior QA Associate Car-t
il y a 1 semaine
Gent, Belgique Johnson & Johnson Temps pleinJohnson & 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...
-
Senior QA Associate Car-t
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinJohnson & 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, Belgique Johnson & Johnson Temps pleinJohnson & 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....
-
QA/qp Support Lead, Car-t Europe
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinJohnson & 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 2 semaines
Gent, Belgique Johnson & Johnson Temps pleinJohnson & 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...
-
Senior QA Associate Release Car-t Europe
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinJohnson & 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 Project/operation Manager Mes Car-t Emea
il y a 2 semaines
Gent, Belgique Johnson & Johnson Temps pleinFlexible work practices, award-winning benefits - This position will be based in Ghent, Belgium. **Change lives for the better.** **THE OPPORTUNITY** **How 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...
-
QA Car-t Qualification Lead Emea
il y a 4 semaines
Gent, Belgique Johnson & Johnson Temps pleinJohnson & 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...
-
QA Project/operation Manager Mes Car-t Emea
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinFlexible 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...
-
Sr QA Associate Car-t Emea
il y a 2 semaines
Gent, Belgique Johnson & Johnson Temps pleinFlexible work practices, award-winning benefits - This position will be based in Ghent, Belgium. **Change lives for the better.** **THE OPPORTUNITY** **How 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...
-
QA Car-t Qualification Lead Emea
Il y a 2 mois
Gent, Belgique Johnson & Johnson Temps plein**CAR-T QA C&Q Engineer** The 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....
-
QA Car-t Qualification Lead Emea
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinJohnson & 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...
-
QA Car-t Qualification Lead Emea
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinCAR-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...
-
Sr QA Associate Car-t Emea
il y a 1 semaine
Gent, Flandre, Belgique Johnson & Johnson Temps pleinFlexible 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 Associate Release Car-t Europe
il y a 2 semaines
Gent, Belgique Johnson & Johnson Temps pleinThe Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Associate Release 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...
-
Quality System Lead
il y a 3 semaines
Gent, Belgique Johnson & Johnson Temps pleinThe 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...