QA Document Control Supervisor

Il y a 2 mois


Gent, Belgique Legend Biotech EU Temps plein

**Company Information**

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

**Role Overview**:
The Quality Assurance Document Control Supervisor role is an exempt level position with responsibilities for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and retention, and document issuance and reconciliation. This role needs to ensure permanence to support the 7/7 days cell processing activities.

**Major Responsibilities**:

- Supervise team of individuals responsible for managing the document control systems and processes for the site.
- Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures.
- Support Document Management system users with workflow handling and electronic system usage.
- Manage the periodic review process for procedures.
- Issuance of batch related documentation in support of GMP manufacturing.
- Reconcile GMP documentation following document lifecycle requirements.
- Responsible for storage and archival of GMP documents and batch related records.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Review and approve SOPs, and other documentation.
- Drive continuous improvement.
- Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.

**Qualifications**

**Education**:
A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.

**Experience**:
**Key Capabilities, Knowledge, and Skills**:

- GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
- Operational experience with electronic quality systems.
- Experience with Document Management Systems (TruVault/Veeva) is preferred.
- Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills.
- Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail.
- Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Flexibility in work schedule is required.
- Effective interpersonal skills with the ability to communicate across all levels of the organization.
- Ability to work independently with a high degree of accountability.
- Proficient knowledge of Microsoft Office.

**Language Requirements**

Dutch and/or technical English

LI-AG1

Legend Biotech maintains a drug-free workplace.


  • QA Release Supervisor

    Il y a 5 mois


    Gent, Belgique MindCapture Temps plein

    QA RELEASE SUPERVISOR - Biotechnology- GhentABOUT THE COMPANY The **QA Release Supervisor** holds a pivotal role, ensuring the quality oversight of personalized cell therapy production for both clinical and commercial requirements within a sterile GMP environment. This position involves supervising QA release associates, collaborating with manufacturing to...

  • QA Supervisor Qpip

    Il y a 4 mois


    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. **Role Overview** The QA Supervisor...

  • QA Micro Supervisor Techlane

    il y a 1 semaine


    Gent, Belgique Johnson & Johnson Temps plein

    CAR-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...


  • Gent, Belgique Legend Biotech EU Young Graduates Temps plein

    As a Quality Assurance Document Control Specialist, you are a cornerstone in our mission to save lives. Together with your colleagues from the Document Control Team, you monitor the integrity of our documents. You manage the document lifecycle, from creation to archiving, ensuring quality and compliance. **What can you expect?** In our GMP-controlled...


  • 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. **Role** **Overview** The QA...

  • QA Specialist

    Il y a 5 mois


    Gent, Belgique MindCapture Temps plein

    QA SPECIALIST - Biotech- GhentWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and resourcefulness in achieving success. We reward you with competitive salaries and offer a strong package of additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on...


  • Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer...


  • Gent, 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...


  • 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....


  • 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 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. **Role Overview**: The **Senior**...


  • Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer...

  • QA Lead Investigations

    Il y a 5 mois


    Gent, 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...


  • Gent, 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...


  • Gent, 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...

  • Sr QA Associate Car-t Emea

    il y a 3 semaines


    Gent, Belgique Johnson & Johnson Temps plein

    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...

  • QA Project Manager, Car-t Emea

    il y a 3 semaines


    Gent, Belgique Johnson & Johnson Temps plein

    Johnson & 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...


  • Gent, 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...

  • QA Micro Associate

    Il y a 5 mois


    Gent, Belgique Johnson & Johnson Temps plein

    CAR-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...


  • Gent, 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....