Senior Manager, GMP QA
Formation BioNew York, New York, United States • Boston, Massachusetts, United States
Posted December 18, 2025
169000 - 200000 USD year
Full Time
About the Company
Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
Job Description
Formation Bio is a tech and AI driven pharma company seeking a Senior Manager, GMP QA to ensure compliance with regulatory requirements and industry standards. The ideal candidate is a hands-on quality champion with strong communication skills and the ability to pivot in a dynamic environment.
Requirements
- Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences)
- Minimum of 10 years’ experience in GMP Quality Assurance within pharmaceutical, biologics, or biotechnology manufacturing and testing
- Deep understanding of GMP expectations (e.g., FDA, EMA, and ICH) and a commitment to patient safety
- Excellent communication, organization, and collaboration skills
- Ability to lead investigations and write clear, concise supporting documents
- Experience with CMO oversight or virtual manufacturing models
Benefits
- Comprehensive benefits
- Generous perks
- Hybrid flexibility
- Equity
