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The Quality Manager is responsible for the quality oversight to assure compliance with relevant Good Manufacturing Practice (GMP) regulations and guidelines to assure the execution of activities within the Technical Research & Development, US, Fort Worth organization. Activities in scope include but may not be limited to assuring adequate systems are in place for the protection of patient safety, data integrity, oversight of local release, and general quality oversight.
Your responsibilities will include, but not limited to;
*Ensures and supports overall GxP conformity & Compliance with the Novartis Quality Management Systems. *Oversight of all production-, logistic and testing activities, ensures compliance with cGxP, incl. data integrity & eCompliance. *Deviation management and change control for production processes, documentation and equipment. *Approval of validation / qualification of processes, equipment, and systems. Preparing and conducting inspections. *Executes batch release in compliance with regulatory filing and Novartis guidelines.