Conduct external vendor evaluation audits to determine qualifications. Maintain the vendor qualification program, which may include multiple sites. Conducts internal quality audits and risk assessments. Prepares audit plans and understands the specific issues to be evaluated. Executes audits to ensure compliance with recognized standards (i.e., GCP, GLP, GMP), regulatory authorities and in-house and external specifications and standards. Reports discrepancies. Develops formal written reports to communicate audit results to management and regulatory compliance agencies, if applicable, and makes recommendations as appropriate. May facilitate work of external auditors during on-site visits. Individual must have strong working knowledge of cGMPs and applicable regulatory guidance. Must possess excellent written and verbal communication skills and the ability to work independently.