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Job Summary:
- Provide GMP quality oversight of CMO/CDMO manufacturing and testing activities.
- Support product disposition and release activities in collaboration with Quality Control and Regulatory.
Essential Duties and Responsibilities:
- Review and approve batch records, deviations, CAPAs, and change controls affecting product quality.
- Lead or support internal and external GMP audits, including CMO/vendor qualification audits.
- Manage quality agreements and represent Quality during health authority inspections.
Qualifications:
- Bachelor's degree in a scientific discipline; 5+ years GMP quality assurance experience in pharma/biotech.
Beeline Medicines
Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. The company is backed by world-class life science investors and led by an established executive team.