Louisville, KY21 days ago
Job Description:Manage required quality activities in the Clinical and Commercial PT distribution and in-country GMP/GDP operations owned by PT, including as applicable: Regulatory readiness activities required to ensure a regulatory compliant supply of clinical and commercial material, such as the quality oversight of Artworks operations; management of GMP documents required for Launches, Variations & Renewals and management of IMP Flowcharts required to ensure compliance to the respective IND/QIMPD. operations, taking place at Transport providers; Warehousing & distribution centers; Partners (including External Sponsors of Clinical Trials, In- / Out-Licensing Partners, Divestment Partners and Co-Promotion Partners); Local CMOs and Laboratories contracted for in-country testing activities.