Sr. Manager Serialization & Product tracking Operations Job ID REQ-10028849
Location: Spain
Summary Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
The Business Process Owner (BPO) for serialization systems is responsible for the Product Security features and serves as the Subject Matter Expert (SME) for serialization requirements across all markets. This role ensures end-to-end process upgrade or creation for serialization/product tracking and regulatory compliance for Track and Trace in both ongoing and upcoming markets by collaborating closely with the country organization, supply chain, sites, and External Supplier Organization (ESO). The BPO will establish and manage Novartis Track and Trace processes to achieve Novartis objectives.
About the Role Major accountabilities:
Provide guidance and direction on serialization & product tracking related activities.
Process and Supply Chain mapping from a serialization and product tracking perspective.
Lead the development and implementation of an effective compliance program for Track and Trace markets and product safety, identifying potential compliance risks associated with business strategies and establishing effective controls and compliance oversight related to those risks.
Develop a compliance program foundation which includes oversight of a Track and Trace program structure and foundation, ensuring that all elements of an effective compliance program are in place and integrated into existing structures and processes where appropriate.
Ensure a thorough understanding of the regulations (both what is required and what is recommended) is used to build the processes, systems, and controls to maintain compliance throughout the product supply chain.
Partner with external trading partners and internal stakeholders to help understand and resolve complex matters such as tracing, verification, and suspect product investigations.
Implement monitoring programs to ensure manufacturing site compliance and exception management.
Lead and support Novartis serialization system implementation around SAP ATTP and SAP ICH system.
Support Novartis internal manufacturing system and contract manufacturing system integration using ATTP, ECC and SAP ICH system.
Design and deploy the serialization solution enhancements in ATTP, SAP ICH systems.
Develop a staffing strategy to meet technical and project deployment priorities for Serialization.
Lead the team responsible for implementing track & trace solutions for the regions.
Understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.).
Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments.
Operational management of GxP solutions including related technologies to support operations.
Experience in GxP qualification activities.
Participation in Industry association forums related to serialization.
Supply Chain and Project Management experience.
Pharmaceutical, Generics experience and SAP experience.
Subject matter expertise in pharmaceutical product serialization, track and trace systems (SAP ATTP, ICH, EPCIS, GS1, etc.) and associated challenges and risks impacting the supply chain.
Significant experience and familiarity with relevant regulatory requirements, including federal/state/international regulations, DSCSA requirements, verification of trading partners, etc.
Strong problem-solving and communication skills to interact with senior leadership and regulatory agencies.
Ability to drive organized, multi-function collaboration, including with non-SC parts.
Languages :
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.
How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
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