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    QA Lead Investigations - Ghent, België - Johnson & Johnson

    Johnson & Johnson
    Johnson & Johnson Ghent, België

    Gevonden in: beBee S2 BE - 6 dagen geleden

    Johnson & Johnson background
    OTHER
    Beschrijving
    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 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 capacity for CAR-T treatments in Europe, both at our existing site in Beerse (QC laboratories) and in Ghent, where we have built two CAR-T manufacturing centers in the Ghent area (Belgium).


    We are looking for strong talents who are eager to participate in this innovative and hopeful venture.

    The QA Lead Investigations, CAR-T Europe is part of the QA/QP Operational team and is responsible to ensure that product and process related investigations, complaints, escalations and change controls are properly handled on time and in line with all ATMP/GMP requirements.



    Key Responsibilities:


    • Act as an expert resource for investigations supporting the QA/QP Operational team.
    • Support in-depth investigations by providing quality and compliance expertise.
    • Ensure that deviations/complaints are timely and properly investigated by providing quality & compliance expertise.
    • Ensure that 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.
    • Contribute to the impact assessment and evaluation of assigned Change Controls.
    • Participation in the (Quality) Operational Governance meeting regarding operational QA activities.
    • Participate to the quality oversight programs of the operational activities by documented QA approval of GMP documentation and support in the different quality review meetings.
    • Support the preparation, execution and follow-up of inspections and audits.
    • Drive continuous improvement.
    • Establish and maintain effective working relationships with the different business partners and Legend Biotech to ensure alignment of objectives and deliverables.
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