Develops and maintains a Quality Assurance Agreement in cooperation with the external partners. Responsible for the initial qualification and onboarding of contract manufacturers as well as for performing regular quality risk assessments. Ensures that all aspects of manufacturing, testing, release and distribution of drug substance/drug product/ intermediate product/material are in compliance with applicable ADACAP and Novartis standards, the effective Quality Assurance Agreement, relevant guidelines and the Quality Management System of the external partners. Manages and oversees contract manufacturer s activities related to quality processes such as deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc. according to the Quality Assurance Agreement and the Novartis Quality Manual. Ensures investigations are appropriately executed within agreed timelines, including documentation and effective measures to prevent recurrence. Support the Novartis audit ...