Description: Leads and conducts external audits to assess the quality / compliance of current Good Manufacturing Practice (cGMP), applicable regulations, and applicable company policies and procedures of external suppliers and contractors on behalf of the BIV-US facilities and external suppliers and contractors on behalf of the BI manufacturing world, including Operations, Development, Biopharma, and Animal Health. Create and issue the audit report for each audit to submit to BIAH management as a means to ensure SOP(s), facilities, systems, processes and studies conform to applicable cGMP, Good Laboratory Practices (FDA, USDA, EU), Good Clinical Practices (FDA), and/or Guidance Documents (FDA, USDA, EU) internally and for external.