Role OverviewResponsible for leading Quality GMP manufacturing and testing activities at external vendors, supporting both early and late phase development and ensuring compliant product release, effective vendor management, and alignment with global GxP standards.
What You Will Do
Provides oversight of Quality Assurance activities at GMP external vendors for manufacturing and testing operations, ensures compliance with global GxP regulations, quality standards and procedures. Oversees and/or performs QA product release activities.
Why It Might Be a Fit
Requires exceptional relationship management skills, ability to use written and verbal communication skills to communicate complex scientific, medical and program issues, ability to partner with cross-functional teams, and outstanding flexibility and adaptability.
Requirements
- Bachelor's degree in a scientific discipline
- minimum of 12 years of GMP Quality/CMC experience
- extensive CMO oversight
- strong leadership, governance, and relationship-management skills
Benefits
- 401k match
- healthcare coverage
- ESPP
- annual bonus
- equity grant
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