QA Investigations Specialist

Il y a 4 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 QA Investigations Specialist, with focus on Investigations and Change Controls, is part of the QA Project Support Team.

The QA Investigations Specialist is responsible for conducting thorough investigations into non-conformances occurred during operational QA activities in both clinical and commercial batches manufactured at Legend Biotech Belgium. This role also involves managing the change control process to ensure all Quality Operation change controls are assessed, documented, and implemented in compliance with regulatory requirements and company policies.

**Major Responsibilities**
- Investigations:

- Conduct detailed investigations into non-conformances
- Gather and analyze data to identify root causes.
- Develop and implement corrective and preventive actions (CAPAs).
- Document investigation findings and ensure timely closure of reports.
- You are in close contact with multiple departments (Operations, Supply Chain, QC, QA,).
- Ensure accurate and timely maintenance and review of investigations, CAPAs
- Change Control:

- Coordinate the change control process for all changes impacting product quality, safety, and efficacy.
- Review and assess change control requests for completeness and accuracy.
- Facilitate change control meetings and ensure all stakeholders are informed.
- Track and monitor the implementation of approved changes.
- Ensure accurate and timely maintenance and review of change controls
- Continuous Improvement:

- Identify opportunities for process improvements and contribute to the development of best practices.
- Provide training and support to staff on investigation and change control procedures.
- You will be responsible for drafting necessary documents, including Standard Operating Procedures and Work Instructions for the users.
- Monitor and report on progress of the project goals and operational project KPIs
- Support regulatory inspections and audits by ensuring inspection readiness within facility.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.

**Qualifications**

**Education**

A minimum of a Bachelor's Degree or relevant years of experience within the pharmaceutical industry.

**Experience**
- A minimum of 2 years relevant work experience is required.
- Prior experience in pharmaceutical manufacturing or quality, is required.

**Key Capabilities, Knowledge, and Skills**
- Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell-based products.
- Excellent analytical, problem solving, and organizational skills
- Effective communication and interpersonal skills
- Proficiency in using quality management systems and software
- Experience with root cause analysis tools and techniques.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective.
- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes.
- Self-motivated, enthusiastic personality, team player, with a desire to learn new skills.
- Ability to work in (transversal) teams - Team spirit.
- Can do attitude, right first time.
- Great attention to detail and ability to follow the procedures.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a must.
- Must exhibit strong leadership skills and effectively develop others.
- Ability to collaborate well with stakeholders, 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.

**Language Requirements**

Dutch and/or English

Legend Biotech mainta

  • QA Lead Investigations

    Il y a 6 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...

  • QA Lead Investigations Car-t Europe

    il y a 2 semaines

    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...

  • QA Specialist

    Il y a 6 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...

  • QA Investigator Supervisor

    Il y a 7 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...

  • QA Investigator Supervisor

    il y a 4 semaines

    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...

  • Operational QA

    Il y a 3 mois

    Gent, Belgique HAYS Temps plein

    Gent | Operational QA | Biotechnology | EN NL | 1105130 In this pivotal role as **_Operational QA_**, you will delve into investigations to identify and resolve issues in the manufacturing process caused by human error. Your contributions will be crucial in ensuring the safety and timely release of our products. If you are passionate about quality and eager...

  • Qc Investigation Specialist

    Il y a 6 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 QC Investigation...

  • Sr. QA Associate Car-t Emea

    Il y a 7 mois

    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...

  • Senior QA Associate Release Car-t Europe

    Il y a 7 mois

    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...

  • QA Csv Manager

    il y a 1 mois

    Gent, Belgique Cerba Research Temps plein

    Cerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to...

  • QA/qp Operation Director Car T

    Il y a 7 mois

    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...

  • QA Lab and Data Integrity Management Car-t

    Il y a 7 mois

    Gent, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab and Data Integrity associate for the CAR-T hub in Europe. The position will be based in Gent Belgium. CAR-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...

  • QA Lab Associate Ipl Car-t

    il y a 2 semaines

    Gent, Belgique Johnson & Johnson Temps plein

    CAR-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...

  • QA/qp Support Lead, Car-t Europe

    Il y a 6 mois

    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....

  • QA Lab Associate Car-t Ipl

    Il y a 6 mois

    Gent, Belgique Johnson & Johnson Temps plein

    The 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 Csv Manager

    Il y a 6 mois

    Gent, Belgique Cerba Research Nederland Temps plein

    Cerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to...

  • QA Micro Associate

    il y a 3 semaines

    Gent, Belgique Johnson & Johnson Temps plein

    **Job Description**: 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...

  • QA Micro Associate

    Il y a 7 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...

  • Senior QAulity Specialist OTC/medical Devices

    Il y a 4 mois

    Gent, Belgique Perrigo Temps plein

    **Description Overview**: Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being. Originating from the former Omega Pharma, the European branch is today present in 30 countries with a strong local anchorage. You know us from brands like Physiomer, NiQuitin, XLS Medical,...

  • QA Micro Supervisor Techlane

    Il y a 2 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...