Sr QA Associate Car-t Emea
il y a 2 semaines
Johnson & Johnson (J&J) is recruiting a Sr QA Associate, QA Operations/Project 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 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 has constructed two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing J&J Beerse site. CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities.
The Sr QA Associate, QA Operations/Project Support Lead, CAR-T Europe is responsible to ensure QA operational support and enhancements to the QA processes in line with all ATMP/GMP requirements.
Major Responsibilities:
- Quality Assurance Oversight: Monitor and ensure adherence to Good Manufacturing Practices (GMP/ATMP) and other relevant quality standards during the manufacturing of CAR T-cell products.
- Project Management: Manage quality aspects of CAR T-cell therapy projects, ensuring milestones and deliverables are met in alignment with project timelines and objectives.
- Risk Management: Conduct risk assessments for CAR T projects, identify potential quality issues, and develop mitigation strategies to address identified risks.
- Document Control: Review and approve project-specific documents, including protocols, standard operating procedures (SOPs), batch records, and validation reports.
- Deviation & CAPA Management: Investigate deviations, non-conformances, and implement corrective and preventive actions (CAPAs) to ensure process integrity and product quality.
- Change Control: Evaluate and implement changes related to CAR T-cell processes, equipment, and materials, ensuring all changes comply with quality standards and regulatory requirements.
- Audits & Inspections: Prepare for and participate in internal and external audits and inspections. Lead audit response activities and implement corrective actions as necessary.
- Collaboration: Collaborate with internal teams and external partners to support the project from development to manufacturing, ensuring quality requirements are met at all stages.
- Continuous Improvement: Establish and maintain effective working relationships with the different business partners and Legend Biotech to ensure alignment of objectives and deliverables.
**Qualifications**:
- Education: Bachelor’s or Master’s degree in Pharmacy, Engineering, Biotechnology, or a related field.
- Experience: Minimum of 5 years of experience in quality assurance or project engineering within the pharmaceutical or biotechnology industry.
- Experience with cell and gene therapy, specifically CAR T, is preferred.
- Regulatory Knowledge: Strong understanding of regulatory requirements, including FDA, EMA, GMP/ATMP and ICH guidelines for CAR T-cell products.
- Technical Skills: Proficiency in quality management systems (QMS), process validation, and risk management tools.
- Soft Skills: Excellent project management, communication, and problem-solving skills. Ability to work effectively in cross-functional teams.
- Certifications: Relevant certifications (e.g., Six Sigma, Black/Green/Yellow belt) are a plus.
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.
-
Sr. QA Associate Car-t Emea
il y a 4 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 Release Car-t Europe
il y a 4 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...
-
QA Associate Car T Emea
il y a 2 semaines
Gent, Belgique Johnson & Johnson Temps pleinJohnson & 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 are created from the patients’ own T cells and are...
-
Senior QA Associate Car-t
il y a 3 semaines
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...
-
QA Associate Release Car-t Europe
il y a 4 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...
-
QA Lab Associate Ipl 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 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 Lab Associate Car-t Ipl
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 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 Manager Car-t
il y a 1 semaine
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a QA Manager 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 Car-t Qualification Lead Emea
il y a 2 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...
-
Sr. QA Micro Associate
il y a 3 semaines
Gent, Belgique Johnson & Johnson Temps pleinCAR-T 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. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results. We are therefore working passionately on expanding our...
-
QA Project Manager, Car-t Emea
il y a 2 semaines
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a QA Project Manager 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...
-
QA Car-t Qualification Lead Emea
il y a 4 semaines
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....
-
Senior QA/qp Manager Car T Emea
il y a 4 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. 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...
-
QA Investigations Associate
il y a 3 semaines
Gent, Belgique Johnson & Johnson Temps pleinApplies in-depth knowledge of Quality Assurance best practices and surfaces issues that may impact organizational objectives. Documents critical Quality Assurance issues in product processes and tracks regulatory changes. Conducts routine collection and dissemination of feedback to ensure continuous improvement of the quality management system. Completes...
-
QA Lab Associate Ipl Car-t
il y a 5 jours
Gent, Belgique Johnson & Johnson Temps pleinCAR-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 system. The patients’ own T cells are harvested and engineered to kill the cancer cells expressing a specific antigen. To bring this life saving therapy to the patients, Johnson & Johnson Innovative...
-
Sr. Manager Quality Systems
il y a 4 semaines
Gent, Belgique Johnson & Johnson Temps pleinJohnson & 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...
-
QA Release Associate
il y a 4 semaines
Gent, Belgique Johnson & Johnson Temps pleinThe QA Associate Release CAR-T Europe is responsible for the release of CAR-T investigational medicinal and commercial CAR-T products manufactured in the Ghent facilities. **Key Responsibilities**: - Taking responsibility as Release Responsible of both investigational medicinal and commercial CAR-T products manufactured at the Janssen/Legend Biotech...
-
QA Qualification Associate
il y a 2 semaines
Gent, Belgique Johnson & Johnson Temps pleinCAR-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. They are...
-
QA Micro Associate
il y a 3 semaines
Gent, Belgique Johnson & Johnson Temps pleinCAR-T 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. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results. We are therefore working passionately on expanding our...
-
QA/qp Operation Director Car T
il y a 5 jours
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...
