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Clinical Quality Manager
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Full-time
- Serve as the GLP/GCP subject matter expert to cross-functional clinical trial teams to ensure that all quality and regulatory compliance activities were conducted in compliance with GCPs, SOPs, and ICH Guidelines.
- Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GLP/GCP.
- Completes preclinical laboratory inspections as directed by study protocol.
- Serves as the Quality Lead for assigned BostonGene clinical research projects providing GCP compliance interpretation, consultation, and other support services necessary.
- Lead GCP/GLP inspections and assist in the surveillance inspections as assigned.
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