Product Quality Leader, Senior Director
4 weeks ago
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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Product Quality Leader, Senior Director
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Princeton, New Jersey, United States Galapagos Full timeProduct Quality Leader, Senior DirectorWe are seeking a highly skilled and experienced Product Quality Leader, Senior Director to join our team at Galapagos. As a key member of our organization, you will be responsible for ensuring the highest quality standards in our products and processes.Key Responsibilities:Develop and implement product quality...
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