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Lead development of CMC strategies from early clinical manufacturing to commercial production. Ensure compliance within CMC manufacturing and oversight of Contract Manufacturing Organizations and testing Labs. Initiate process improvement and process control procedures for cGMP manufacturing and product quality. Provide technical oversight of batch records, protocols, cha
Posted 1 day ago
Serve as Subject Matter Expert (SME) on CAPA process in cross business unit network Influence cross functional peers to align on standard methodologies within the network on process/system tools used to manage CAPA Perform data analytics around Quality system process (CAPA and similar) performance Prepare and present metrics related to quality system elements for senior m
Posted 14 days ago
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