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Check out JobsAI Associate Director, Quality Operations, CMC
Company Name
Praxis Precision Medicines, Inc.
Job Overview
The Associate Director/Director, Quality Operations, CMC is responsible for operational activities ensuring product quality and compliance in the manufacture, testing, control, validation, and release of drug substance and product. They serve as the quality expert for Praxis' neurological disease product pipeline, making strategic quality decisions throughout the product lifecycle.
Responsibilities
- Overseeing contract service providers
- Reviewing strategic documents
- Supporting stability programs
- Leading investigations
- Performing risk assessments
- Participating in regulatory inspections
Requirements
- BA/BS in Chemistry or related field
- 8+ years in a GMP setting