Product Quality Leader, Senior Director

4 weeks ago


Princeton, New Jersey, United States Galapagos Full time
Product Quality Leader, Senior Director

We are seeking a highly experienced Product Quality Leader, Senior Director to join our team at Galapagos. As a key member of our Product Quality organization, you will be responsible for developing and implementing end-to-end product quality strategies for new product classes or modalities, ensuring compliance with regulatory requirements and specifications.

Key responsibilities include:

  • Developing and implementing product quality strategies for new product classes or modalities
  • Ensuring compliance with regulatory requirements and specifications
  • Collaborating with cross-functional teams, including Manufacturing, Quality, Process Development, Analytical Development, MSAT, Supply Chain, and CMC leadership
  • Providing expert-level assessment of product quality during technical issues
  • Authoring, reviewing, and approving regulatory documents and filings

Requirements:

  • Science degree - post graduate degree (MS or PhD) preferred
  • At least 14 years' experience in pharmaceutical/biopharmaceutical manufacturing and quality operations
  • Strong knowledge of CMC and Quality requirements
  • Extensive knowledge of the pharmaceutical/biopharmaceutical industry

We offer a comprehensive benefits package, including performance bonus plan and long-term incentive program. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.



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