Jesus Arias Sanchez

• Verify and ensure that the External Supply Operations area comply with the Quality Management System
• Responsible for managing QMS Documents, (SOPs, WPs, WIs, FRMs) issuance, updates, withdrawals & periodic reviews from initiation until completion, assuring that the processes adhere to the Sandoz QM directives, Global SOPs, Health Authorities requirements
• Provide support to Business Partners and Global activities/initiatives, ensuring efficient, timely, and clear communication to all involved partners.
• Follow-up on the actions determined by audits, self-Inspections
• Responsible for Quality Oversight (change controls) of third-party sites for commercial manufacturing (CMO) Europe, USA, Latam and Canada markets
• Provide change management end-to-end process to different countries; as the Change Manager, assuring the main regulatory guidelines are in compliance with FDA, HA Canada, and COFEPRIS.
• Change Review Board (CRB) facilitator for ESO US
• Demonstrate customer-oriented service mindset in handling and executing deliverables
• Report and record Issues, Deviations, Quality Events management emerging from Service delivered
• Trains and coach users, participates in Knowledge Snacks and cascades information related to the IT platform and its capabilities related with change control management.
• Provided training and guidance to staff on operational procedures, policies, and regulations.
• Single Point of Contact for the Change Control Process at Global Quality Solutions area.

Focused on Change Control and Training Administration systems:

• Ensure continuous data governance in SharePoint and local system, maintain the site-specific training curriculum on behalf of local site training experts
• On-time follow-up of change control records using weekly reports.
• Software and database management for QMS control (TrackWise, SAP, Agile PLM).
• Automatization of quality KPIs database through Power BI/Qlik Sense.
• Staff training on the SOP of the change control system and in Good Documentation Practices.
• Elaboration of visual communications that improved the clarity of the quality management process.
• Identified needs of customers promptly and efficiently.
• Support user resource list and training matrix for new training assignment, removal, and updates.