Position Summary: The Director, Global Product Quality provides guidance and expertise to OAPI/OPDC in the interpretation and implementation of manufacturing and quality system regulations applicable to commercial drug products, medical devices and combination products. Ensures that SOPs describing internal processes are developed and maintained and that the appropriate quality audits are conducted and responded to in order to maintain compliance with GMP regulations and guidelines. Host FDA for on-site GxP inspections Provide global expertise for data integrity across GxP functions Designs and implements institutional quality management systems and quality programs to ensure sustained GMP/QSR compliance.
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