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Position Summary:
- Responsible for a variety of operational activities pertaining to assuring product quality and compliance.
- Serve as the quality expert for the Praxis pipeline of neurological disease product programs.
- Responsible for making strategic quality decisions throughout the product lifecycle end-to-end.
Primary Responsibilities:
- Development, maintenance, and review of clinical and commercial Quality Agreements.
- Ensure cohesive collaboration across CSPs for timely review of manufacturing records
- Ensure robust processes are implemented for product management
Qualifications and Key Success Factors:
- 5 + years in a GMP setting working with clinical and commercial products
- Firsthand experience with interpreting and implementing of regulatory standards
- Proven track record and experience in supporting regulatory inspections
Praxis Precision Medicines
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.