Product Quality Associate, Batch Record Review

☞ Argenx

Ver: 125

Día de actualización: 16-11-2025

Ubicación: Ghent East Flanders

Categoría: Mecánica / Técnica Mantenimiento

Industria:

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Contenido de trabajo

To further strengthen our Quality team, we are looking for an experienced and motivated Product Quality Associate, Batch Record Review. The Product Quality Associate, Batch Record Review will play a role in further build out of Product Quality infrastructure at argenx in close collaboration with internal business teams and who will be responsible to follow-up on the timely completion of Batch Record Review to support the commercial forecast and clinical supply.

This position can be filled in permanently or through consultancy.

Key Accountabilities and Responsibilities:

  • In close collaboration withexternal and internalmanufacturingand supplyteams from both CMO and the company:
    • Coordinate the batch record review and approval process ensuring timelines are met
    • review of executed batch record documentation of development and commercial Drug Substance and Drug Product batches
    • review batch record documentation and support release of finished IMP for clinical studies
    • support release of commercial product to different markets
    • review of deviation investigationsrelated to manufactured batchesand related corrective and preventive actions
  • Monitoring of the performance of the manufacturing processes through metrics
  • Contributes to internal and external audit planning and follow-up.
  • Support the further build-out of quality processes and systems.
  • The role may also support the QA team with additional ad hoc project support

Desired Skills and Experiences:

  • 3y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological manufacturing operations.
  • Experience with Batch Record Review is a plus.
  • Experience with working in an outsourced model, closely collaborating with a CMO is and asset.
  • Experience with audits is a plus.
  • Knowledge of FDA and EU regulations and ICH Guidelines.
  • Strong technical mastery, analytical and investigation skills
  • Accurate in execution and reporting, quality-minded.
  • Able to work effectively together with both internal and external stakeholders.
  • Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines.
  • Fluent in English – our working language.

Offer:

  • A competitive salary package with extensive benefits
  • Front seat in the development of therapeutic antibodies
  • A work environment in a human-sized, dynamic and rapidly growing biotech company
  • Possibility to work remotely with limited travelling required
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Plazo: 31-12-2025

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