Support the of Clinical Supply Quality in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities. * Support the systems and processes in place for the appropriate documentation of the company development activities and to maintain them in a manner compliant with regulatory and corporate requirements. * Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits. * Contribute the preparation of audits (internal/external, regulatory inspections) * Lead internal audits / Self-Inspections Process * Ensure Clinical Supply Quality processes directly support Technical Operations and goals and objectives
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