Product Quality Associate, Batch Record Review

☞ Argenx

Aussicht: 125

Update Tag: 16-11-2025

Ort: Ghent East Flanders

Kategorie: Mechanische / Technische Pflege

Industrie:

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Jobinhalt

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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Frist: 31-12-2025

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