QMS Specialist

☞ Legend Biotech

View: 115

Update day: 25-11-2025

Location: Ghent East Flanders

Category: Other

Industry: Biotechnology Research

Position: Mid-Senior level

Job type: Full-time

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Job content

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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

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.

Position Overview

The QMS Specialist will provide oversight of all GMP documents and ensure that all documents are updated and effective in alignment with the needs of CAR-T Operations and document lifecycle management. They will also be responsible to prescribe the correct training based on the type of changes made. And maintain both the procedures as the trainings in the electronical systems.

Major Responsibilities

  • Introduction of new SOPs in time to support Manufacturing Strategy.
  • Ensure periodic review of all SOPs are completed on time.
  • Liaison with all relevant departments to ensure alignment for new SOPs and changes to existing SOPs.
  • Ensure procedures are kept up to date in the electronical document management system.
  • Ensure proper training is prescribed as per the document changes made.
  • Ensure training is added in the electronical Learning management system.
  • Build and maintain curricula in the electronical learning management system.
  • Continuous improvement of all QMS documents to ensure they are streamlined and robust, easy to use and intuitive; to help ensure maximum prevention of operational errors and quick turnaround times.
  • Ensure QMS documents incorporate all latest regulatory and quality requirements and stay current regarding industry standards.

Qualification

Education:

  • Bachelor’s degree in Scientific discipline or equivalent work experience in document creation

Capabilities, Knowledge, and skills:

  • 3-5 or more years of related experience in cGMP/FDA regulated industry is preferred
  • Pharmaceutical GMP’s – strong knowledge of Good Manufacturing Practices and regulatory knowledge is preferred
  • Must be Proficient in MS Office applications and other related IT Systems.

Language(s):

Dutch / English

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

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Deadline: 09-01-2026

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