#LI#CDMX #Hybrid
About the role:
We are seeking a Team Lead for Quality Operations Partner (QOP) is a Global Operation Center providing specialized solutions to a wider Quality Network so candidates will have the opportunity contribute by positively impacting business objectives. This role will work cross-functionally supporting mainly Region Americas. The role will also have the opportunity to participate within Global Strategic projects for the QA and QC Organization
Main Responsibilities:
•Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures
• Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support exception investigations
• Review and approval of production, QC, and AS& T records -MBR review
• Support OpEx improvement projects Qualified Person
• Executes batch release in compliance with registration )
• Global Stakeholder management (internal and external)