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Develop, implement, and maintain the quality management system applicable to R&D activities (SOPs, work instructions, standards, etc.). Ensure compliance of R&D projects assigned to CMO Office with relevant regulations (e.g., GCP, GVP, GMP, GLP, ISO, ICH,
Act as key point of contact for TPM on all operational aspects - equipment, performance, cycle time, yield etc. Build solid relationships with first tier TPM’s and drug linker TPM’s to monitor manufacturing performance weekly through the application