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audits gxp gmp glp regulatory submissions📋 Description
- Lead Quality Systems and GxP compliance globally
- Oversee QMS ops: change control, deviations, CAPAs, audits, complaints, supplier management
- Implement, validate, and maintain Veeva QMS
- Manage QMS training and completion metrics
- Develop internal audit program for regulatory readiness
- Collaborate with Quality, Regulatory, Clinical Ops, IT, Manufacturing and site leadership
🎯 Requirements
- B.S. in a scientific/technical field; advanced degree preferred
- 10+ years biotech/pharma quality with GxP
- Lead QMS ops, audits, and regulatory submissions
- Veeva or other QMS implementation experience
- Experience with FDA/EMA and global regulators
- Proven track record building high-performing teams
🎁 Benefits
- Annual bonus eligibility and equity
- Comprehensive benefits package
- Hybrid work arrangement in Somerville, MA
- Career growth and leadership opportunities
- Collaborative, fast-paced biotech environment
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