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Senior Manager, QA Technical Operations
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Full-time
- Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, and promotions, identifying opportunities and provide the means for employees to pursue career growth.
- Provide quality guidance on process qualification, and continuous process verification strategies for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally and at CMOs.
- Review and approve the Validation Master Plan (VMP) for manufacturing process, aseptic process, and shipping validation, working cross-functionally with key stake holders and responsible functions to ensure the defined VMP activities are executed, maintained and all supporting documentation is complete and accurate.
- Perform quality review and approval of manufacturing process, aseptic process, and shipping validation protocols, performance, and final summary report.
- Provide QA Validation support and expertise to CMC and Tech Transfer teams.
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