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GCP Clinical Quality Assurance, Senior / Executive Director
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- 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases.
- Senior Director of GCP Clinical Quality Assurance
- These responsibilities involve working closely with Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs, CROs, CDMOs, Clinical Trial Sites, and laboratories.
- Establish and maintain the 89bio GCP QA programs, policies, and procedures and ensure cGCP compliance of clinical trials.
- Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.
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