Manager, IT Track and Trace (Information Technology)
The Manager, IT Track & Trace will be responsible for the planning and execution of activities associated with the serialization and security of commercial products globally, as well as processes related to the rollout and operations of critical programs, including traceability, Verification Router Service (VRS) and anti-counterfeiting. The individual must have a strong understanding of systems validation to ensure that any packaging and labeling computerized systems (i.e. systems to support DSCSA, FMD, DGFT and other regional requirements) are compliant with Amneal quality systems as well as how to manage integration of data with other CMO's.
Collaborate with external Supply Chain partners (CMO's, 3PLs, Wholesalers, Distributors, Customers) for real time visibility to support serialization activities The individual will collaborate and participates with both internal and external project teams related to Serialization and Product Security.
Assist in technical problem solving by collaborating with CMOs and Quality to resolve technical and compliance issues. Support the on boarding efforts for new and ongoing programs as requested including but not limited to integration with CMO's, Internal Packaging Line, on-going process improvements for existing products.
Provide support for packaging and labeling product security initiatives globally. Collaborate on and review qualification protocols for appropriate test design and execution.
Monitor serialization and track and trace regulatory requirements and bring necessary compliance requirements in Amneal at all level of serialization project.
Should be able to manage software applications for Track and Trace that Amneal has and should also be able to provide technical support in case of any issues with these applications.
Facilitate supply chain projects requiring technical interface - system or process enhancements, solution implementation, and new technology installation with IT, Master Data Management, Engineering, QA, service and technology vendors.
Monitor and provide technical support for L4/L5 Serialization systems (rfxcel)
Provide Project Management interface for Supply Chain, facilitating new partner and product set up in ERP/MDM/Serialization system.
Accountable to investigate and verify negative responses to salable return verification requests
Ability to identify issues and risks. In conjunction with the stakeholders, formulate plans to mitigate risks.
Manage project budget and resource allocations.
Coordinate and conduct regular project team meetings. Follow up and report on IT/IS, Engineering, Supply Chain, Sales Ops, QA and Validation deliverables, issues, risks and to-do's
Implement and manage project changes and interventions to achieve project outputs
Bachelors Degree in IT/ Supply Chain/ Engineering or equivalent - Required
2 years or more in Track and Trace/Serialization
5 years or more in IT, Manufacturing and Supply chain background
5 years or more in Related business experience in the Pharmaceutical industry or related regulated industry experience and demonstrated leadership in leading cross-functional teams.
A minimum of 3 years' experience and in-depth knowledge of cGMP requirements of the Global Supply Chain Security program, including Serialization, Track-and-Trace, e-pedigree, Anti-counterfeiting technology, and Product Authentication - Advanced
Experience with executive level interactions and influence with Manufacturing Operations, Packaging Technology, Information Technology, Compliance, Quality Assurance, and Supply Chain. - Advanced
Ability to read/write EPCIS(XML) files and understanding of GS1 standards. - Advanced
Good understanding of database application such as MSSQL, MYSQL, Oracle and should have worked and provided technical input on Packaging line systems such as Systech, ACG and Optel. - Advanced
Solid understanding of and experience with the Drug Supply Chain Security Act (DSCSA). - Advanced