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QA Program Lead PoC

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Leiden, Zuid-Holland, Nederland Galapagos Voltijd

About Galapagos

We are a dynamic and growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.

Our Mission

We are committed to changing lives by discovering and developing life-improving medicines. We pioneer for patients and need thought leaders and rapid thinkers who are entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists are essential to our success.

Job Summary

We are seeking a highly motivated QA Program Lead PoC (Associate Director) to support our QA point-of-care operations team in setting up, promoting and maintaining the QA model in our dynamic business environment.

Key Responsibilities

  • Materials Management
    • Set up and manage initial material qualification, specification review, recalls, and change management.
    • Act as the QA partner for the materials kitting process.
  • Vendor Management
    • Oversee risk-based vendor management activities for materials and equipment vendors.
    • Maintain a constructive relationship with critical suppliers.
    • Risk assess, support audits, and QAA management for all vendors.
  • Equipment Management
    • Manage qualification support and release relevant equipment for production.
    • Build and maintain a relationship with critical equipment suppliers.
  • Point-of-Care Operations QA Support
    • Support the front-line-support team in continuous batch support.
    • Drive and manage batch-related cross-functional meetings to support timely batch release.

Requirements

As our QA Program Lead PoC, you will report to the QA Manufacturing Operations Lead, in the IMP QA Oncology team based in our Central EU site in Leiden, NL.