QA Lead Investigations

il y a 1 semaine

Gent, Flandre, 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 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 indepth 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 followup 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.

Qualifications:

Education:

  • You have a Master's Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry) with at least 5 years cross functional experience in the pharmaceutical industry.
  • A certified Industrial Pharmacist (Qualified Person) is a plus.

Experience and Skills:

Required:

  • Experience working in Quality Assurance.
  • Indepth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes.
  • You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating crossfunctional issues.
  • Your verbal and written communication skills enable you to proficiently negotiate and communicate with external and internal customer and partners.
  • Highly organized and capable of working in a team environment with a positive attitude under some supervision.

Preferred:

  • Experience with aseptic processing and technics is preferred.
  • Uptodate knowledge and indepth understanding of relevant pharmaceutical legislation related to clinical trials and cGMP regulations related to manufacturing of cell therapy products is an asset.
  • Knowledge of Good Tissue Practices is considered a plus.

Other:

  • You like to explore new paths, to make full use of your knowledge and experience, as well as to expand it, so that new problems also get solutions.
  • You see possibilities and you look for them, even when they are not immediately clear.
  • You like to work in a team towards a common goal.
  • You consider diversity an asset.

Our offer

  • The opportunity to participate in a progressive treatment that gives hope to patients in need.
  • Being able to help shape a new venture from the start.
  • An innovative working environment.
  • Training on the job for this specific treatment.
  • Opportunities to continue to develop and grow in an extensive and strong organization.
  • An openended contract and a competitive remuneration package.
  • 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._

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