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Check out JobsAI Sr Mgr/Associate Director, GMP Quality Assurance
Location
Boston, San Diego, Remote (Boston)
Company
Kura Oncology, Inc.
Job Overview
The Sr Mgr/Associate Director, GMP Quality Assurance will collaborate with the CMC department and external Vendors to ensure oversight and compliance. They will manage GMP activities related to Regulatory Standard Materials, Intermediates, Drug Substances, and Drug Products. The role involves continuously improving and maintaining Quality Systems related to GMP activities, maintaining documentation for compliance with quality and regulatory standards, and collaborating closely with internal cross-functional teams and management.
Responsibilities
- Planning and overseeing GMP activities
- Reviewing vendor documentation
- Generating quality metrics
- Providing QA leadership