Product Quality Manager

☞ argenx

見る: 175

更新日: 26-11-2025

場所: Ghent East Flanders

カテゴリー: 品質保証/品質管理

業界:

レベル: Mid-Senior level

ジョブタイプ: Full-time

Loading ...

仕事内容

To further strengthen our Quality team, we are looking for an experienced and motivated Product Quality Manager. The Product Quality Manager will support the Product Quality team in the continuous improvement of Product Quality infrastructure and will be responsible for operational management of manufacturing, testing laboratory and release-related Quality activities at argenx. The Product Quality Manager will play a role in the day to day activities within the Global Quality Group in close collaboration with internal business teams.

Key Accountabilities And Responsibilities
  • Support the further build-out of quality processes and systems and provide strategic GMP guidance to third-party vendors and partners to ensure quality and compliance of argenx products.
  • Participate in the following quality assurance activities:
    • Review of product complaints
    • review of deviation investigations and related corrective and preventive actions
    • review of change controls
    • review batch record documentation and support release Product
    • support annual product reviews
    • organize mock recall
    • conduct or oversee self-inspections
  • In close collaboration with the manufacturing teams and Product Quality Managers:
    • review (test method) validation and qualification protocols and reports
    • review stability plans and reports
    • review Specification documents and Certificates of Analysis
  • monitoring of the performance of the analytical methods through metrics
  • Contributes to internal and external audit planning and follow-up.
  • Review quality agreements with external parties.
  • Support the Global External Audit Program through the execution of qualification audits and routine GMP audits of argenx supply chain; Support HA inspection, pre-approval inspections and work with internal stakeholders and external parties to prepare for these inspections.
  • Support follow-up of the above audits and inspections and ensure appropriate and timely CAPA implementation.
  • The role may also support the QA team with additional ad hoc project support
Desired Skills And Experiences
  • 5y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in GMP/GDP and biological analytical methods.
  • Experience with lab activities is a plus
  • Experience with audits and experience with preparation of regulatory inspections (FDA, EMA, PMDA ) is a plus.
  • In-depth knowledge of FDA and EU regulations and ICH Guidelines.
  • Leadership and collaboration skills, including excellent verbal and written communication skills at all levels.
  • Ability to work independently and to make decisions based on experience.
  • Expected to be versatile and flexible and to independently manage projects and make sound decisions related to product quality issues.
  • Strong technical mastery, analytical and investigation skills.
  • Accurate in execution and reporting, quality-minded.
  • Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines.
  • Able to work effectively together with both internal and external stakeholders.
  • Fluent in English – our working language.
Offer
  • Consultancy contract
  • Front seat in the development of therapeutic antibodies
  • A work environment in a human-sized, dynamic and rapidly growing biotech company
Job Info
  • Type: Full time
  • Location: Gent
Loading ...
Loading ...

締切: 10-01-2026

無料の候補者に適用するにはクリックしてください

申し込む

レポートジョブ
Loading ...

同じ仕事

Loading ...
Loading ...