Novartis
AssociateDirectorDDITOPSSPTProcess
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Associate Director DDIT OPS SPT Process at Novartis. Skills: serialization/aggregation processes, process management, cross-functional coordination, vendor/stakeholder management, resource planning, continuous improvement. defining and managing serialization/aggregation processes in impacted areas such as manufacturing, warehouse and supply chain in line with regulatory requirements and Novartis objectives. Own, define and map serialization and product tracking processes in manufacturing, wareho”
Industry & Context.
help understand and resolve more complex matters such as tracing, verification, and suspect product investigations
What They're Looking For.
Must Have
Bachelor's degree in a technical field, 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, Experienced in the operational management of GxP solutions including the related technologies to support the operations, Experience in GxP qualification activities, 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., Ability to drive organized, multi-function collaboration, including with non-SC part.
What You'll Do.
defining and managing serialization/aggregation processes in impacted areas such as manufacturing
warehouse and supply chain in line with regulatory requirements and Novartis objectives
define and map serialization and product tracking processes in manufacturing
warehouse and supply chain
Define standard global process and ensure alignment and implementation at local level (manufacturing sites
warehouses) as well as in global supply chain (e. g. third-party logistics
Ensure end-to-end process documentation in regard to serialization/aggregation is available and maintained updated on ADONIS as process master data repository
Identify opportunities for process optimization and drive initiatives to enhance process efficiency
Define optimum metrics and KPIs needed to measure process performance
Ensure the SPT documentation in QMS reflects updated requirements and processes and follows the simplification approach defined for QMS
Define new documents if needed and execute periodic review of documents
Lead identification of process automation opportunities and work on the implementation of the solutions / technologies
Provide guidance and direction on serialization & product tracking related activities
Partner with external trading partners and internal stakeholders to help understand and resolve more complex matters such as tracing
and suspect product investigations
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
How You'll Work.
Team & Collaboration
Partner with external trading partners and internal stakeholders; Ability to drive organized, multi-function collaboration, including with non-SC part.
Communication Scope
Effective Communication
Process & Methodology
Supply Chain and Project Management experience
Full Job Description
**Job Description Summary** The Associate Director for Serialization and Product Tracking Process is responsible for defining and managing serialization/aggregation processes in impacted areas such as manufacturing, warehouse and supply chain in line with regulatory requirements and Novartis objectives. **Job Description** **Major accountabilities:** * Own, define and map serialization and product tracking processes in manufacturing, warehouse and supply chain. Define standard global process and ensure alignment and implementation at local level (manufacturing sites, warehouses) as well as in global supply chain (e.g. third-party logistics, order management, etc) * Ensure end-to-end process documentation in regard to serialization/aggregation is available and maintained updated on ADONIS as process master data repository. * Identify opportunities for process optimization and drive initiatives to enhance process efficiency, effectiveness, and quality. * Define optimum metrics and KPIs needed to measure process performance. * Ensure the SPT documentation in QMS reflects updated requirements and processes and follows the simplification approach defined for QMS. Define new documents if needed and execute periodic review of documents. * Lead identification of process automation opportunities and work on the implementation of the solutions / technologies. * Provide guidance and direction on serialization & product tracking related activities * Partner with external trading partners and internal stakeholders to help understand and resolve more complex matters such as tracing, verification, and suspect product investigations. * 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. **Minimum Requirements:** * Bachelor's degree in a technical field. * Understanding of global regulations and Health Authorities expectat
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