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Primarily conduct global vendor audits for GDP suppliers. Support and/or conduct audits of providers of warehouse/distribution in support of clinical and commercial oral and parenteral dosage formulations and associated medical devices as assigned. Manage all aspects of the audit lifecycle, including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing. Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team. Work directly with cross-functional departments to gather key information and feedback prior to conducting vendor audits to ensure effectiveness. Align, strategize, and collaborate with the Global Product Distribution & Affiliates to address compliance risks and escalate issues to appropriate levels of management for resolution. Promote awareness across the biologics commercial and clinical manufacturing platforms of current regulatory agency requirements and trends, and develop and report on the trends identified to better focus the scope of audits. Drive consistency with audit report observation writing, classification, status, and overall risk. Conduct due diligence assessments as part of global expansion as required.
