Senior Manager, Quality Operations - Commercial & Stability, CMC
Praxis Precision Medicines, Inc.United States
Posted December 17, 2025
120000 - 132000 USD year
Full Time
About the Company
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.
Job Description
Senior Manager, Quality Operations - Commercial & Stability, CMC. Responsible for overseeing 3PL contract service providers, managing stability programs, and ensuring compliance with regulatory requirements.
Requirements
- BA or BS degree in Chemistry or related field
- 6 + years in a GMP setting working with clinical and commercial products
- Experience managing stability programs
- Direct experience with recall, APR, FAR management
- Firsthand experience with interpreting and implementing of regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA)
- Proven ability to operate independently, influence cross-functionally, and make clear, timely decisions
- Proven track record and experience in supporting regulatory inspections (FDA, EMA)
- Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products
Benefits
- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans
- Matching dollar-for-dollar up to 6% on eligible 401(k) contributions
- Long-term stock incentives and ESPP
- Discretionary quarterly bonus
- Flexible wellness benefit
- Generous PTO
- Paid holidays and company-wide shutdowns