Emplois actuels liés à QA Investigator Supervisor - Gent - Legend Biotech EU

  • QA Investigator Supervisor

    il y a 5 jours

    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 Investigator

    il y a 6 jours

    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 Release Supervisor

    il y a 1 semaine

    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 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...

  • Be QA Release Supervisor

    il y a 2 semaines

    Gent, Belgique Legend Biotech Temps plein

    **Company Information** 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). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an...

  • Car-t Operations Supervisor

    il y a 2 semaines

    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 CAR-T Operations...

  • Senior Medical Writer

    il y a 6 jours

    Gent, Belgique Argenx Temps plein

    For the expansion of our team, argenx is looking for a Senior Medical Writer, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs),...

  • Quality Assurance Manager

    il y a 6 jours

    Gent, Belgique DeLaval Temps plein

    The Product Portfolio Milk Quality & Animal Health (PP MQAH) produces and distributes chemical products by, among others, the Chemicals Division in Drongen (Ghent). The Product Portfolio consists of udder hygiene products, hoof disinfectants and detergents used by dairy farmers around the world. We are currently looking for a **Quality Assurance Manager...

  • Car-t Operations Support Lead

    il y a 3 jours

    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 CAR-T Operations...

  • Team Lead Sample Handling Coordinators

    il y a 1 semaine

    Gent, Belgique Viroclinics-DDL Temps plein

    In this position you will lead the team of **Sample Handling Coordinators** in their daily tasks required in the Sample Handling Department. You will ensure that key daily activities are completed while mentoring the team, driving process improvement initiatives, and supporting the Sample Handling Manager as required. **Your responsibilities**: - Lead...

QA Investigator Supervisor

il y a 1 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 Investigator Supervisor is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in an aseptic GMP environment.

This includes hiring, development and performance management of staff, reviewing/approving operational procedures, supporting and approving manufacturing investigations and ownership of various department projects. She/he will be responsible for multiple work centers within the facilities including tracking of quality metrics while ensuring high quality and compliant product supply.

This role will provide direct leadership to QA Investigators (Quality Leaders) for managing deviations/investigations, and monitoring Quality metrics.

**Major Responsibilities**:

- Supervise a team of QA Investigators.
- Responsible for onboarding and training of QA Investigators.
- Provide guidance to the QA Investigators (Quality Leaders) about handling the various non-conformances.
- Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
- Support the QA Investigators in meetings with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.
- Perform timely escalations of potential significant quality issues to management.
- Escalate to management about issues delaying product release or investigation closure.
- Review and approve critical level investigations and supporting corrections and CAPAs.
- Lead continuous improvement associated with investigation management.
- Provide oversight for execution of internal housekeeping audits.
- Provide oversight for trending of quality compliance metrics.
- Review and approve manufacturing procedures.
- Support all activities for site Quality Operations in accordance with Legend and Janssen (where applicable) standards, procedures and cGMPs.
- Support regulatory inspections and audits by ensuring inspection readiness within facility.
- Other duties will be assigned, as necessary.

**Qualification**

**Education**:
A minimum of a Master Degree in Pharmaceutical/Biological/Biochemical Science/Bio engineering related or equivalent technical discipline is required.

**Experience**:
**Capabilities, Knowledge, and skills**:

- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
- Knowledge of Nonconformance and CAPA management process
- Leadership, project and people management skills
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a must.
- Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
- Must exhibit strong leadership skills and effectively develop others.
- Ability to collaborate well with stakeholders, partners, customers and peers.
- Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
- Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
- Ability to manage conflict and issues that arise with internal or external customers.
- Great attention to detail and ability to follow the procedures.

**Language(s)**:
Dutch & Technical English

LI-AG1

Legend Biotech maintains a drug-free workplace.