Director of Quality Control Operations

7 dagen geleden


Leiden, Zuid-Holland, Nederland Galapagos Voltijd

Welcome to Galapagos, a pioneering biotech firm dedicated to transforming lives through innovative solutions.

Our mission at Galapagos is to create a meaningful and positive impact on society by discovering groundbreaking therapies for diseases that currently lack effective treatments. We aim to build a diverse portfolio of therapies that can potentially redefine existing treatment methodologies.

With aspirations to emerge as a leading global biopharmaceutical entity, Galapagos focuses on the discovery, development, and commercialization of cutting-edge medicines that enhance the quality of life for patients. Our historical emphasis on developing first-in-class therapies through the identification of novel targets in inflammation and fibrosis has led to the successful introduction of our first medicine for rheumatoid arthritis in 2020 and for ulcerative colitis in 2021.

Galapagos is embarking on an exciting new phase to broaden and diversify its pipeline, beginning with oncology, particularly in CAR-T cell therapy, a revolutionary approach to treating various cancer types. The strategic acquisitions of CellPoint and AboundBio position us at the forefront of next-generation cell therapies. CellPoint introduces an innovative, decentralized point-of-care manufacturing model for cell therapies, promising efficient treatment timelines and improved patient outcomes.

We are seeking a highly skilled Associate Director to oversee the QC Lab Operations and QC Support teams.

Key Responsibilities

  • Lead and mentor the QC Lab Operations and QC Support teams, leveraging hands-on expertise to guide compliance and process prioritization.
  • Develop and execute both short-term and long-term strategies for testing processes, laboratory maintenance, equipment lifecycle management, and sample oversight.
  • Ensure GMP readiness for internal laboratories and associated processes.
  • Conduct and manage risk assessments as necessary.
  • Guarantee that the processes established within the teams are compliant, straightforward, and efficient.
  • Collaborate across departments to ensure alignment and clear communication of strategies and processes.
  • Author, review, or approve relevant procedures, protocols, and reports.
  • Assist with compliance-related matters, including deviations, CAPAs, and change controls.
  • Support regulatory submissions and address inquiries from health authorities, including inspections.


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