Director, External Quality Assurance
Sana BiotechnologyCambridge, Massachusetts, United States
Posted December 2, 2025
200000 - 250000 USD year
Full Time
About the Company
Sana is a company that believes in the potential of engineered cells as medicines and is committed to providing a workplace free of discrimination and harassment.
Job Description
The Director of External Quality Assurance will provide leadership and quality oversight for operations at Sana CDMOs, performing Quality person in the plant (PIP) activities and supporting external audits of Sana's suppliers and contract services. The role will require approximately 30% travel.
Requirements
- Bachelor's or Master's degree
- 10-12 years of work experience
- Experience in working with CDMOs in various product lifecycle stages
- Operational experience in manufacturing aseptic environments, in quality or manufacturing
- Experience in leading and managing complex investigations
- Experience in batch disposition activities
- Familiar with US, EMA, and ICH regulations and guidance documents
Benefits
- Generous paid time off
- 401k Matching
- Retirement Plan
- Tuition Reimbursement
- Employee Stock Purchase Plan
- Commuter subsidy
- Wellness offerings