Senior Manager, Serialization Data Operations

Principle Objective of Position

Manage serialization data operational challenges affecting BMS sites, CMOs, 3PLs and BMS customers. Lead effort to analyze and mitigate serialization data challenges by market. Lead efforts to analyze and implement the new regulatory data reporting requirements for new or existing serialized markets. Support management initiatives to develop a digitization strategy to enable faster and effective decision-making. SME in serialization data management, resolution of data exceptions, support data work stream for various serialization implementations, as well as provide ongoing continuous improvement support to sustain the serialization regulatory requirements globally. Support data work stream during various business development activities, such as divestures, acquisitions, new product launch & product life cycles to support business units.

Major Duties and Responsibilities

• Support and maintain Serialization Operations data workstream.
• Assure overall Serialization Operations data objectives are achieved (e.g. right-first time).
• Build and maintain strong relationships with stakeholders across functional areas (e.g. Logistics, O2C, Master Data and Packaging for internal / external, Quality, IT).
• Ensure full consideration of Serialization related data requirements across functional areas.
• Responsible for maintaining technical solutions to ensure timely compliance with all market serialization regulatory requirements.
• Champion data work stream collaboration with partners for existing and new product introduction.
• Perform analysis and recommend mitigation strategies to teams in support of partnerships; collaborate to ensure sound decisions; ensure projects remain on track and CAPAs are closed on time.
• Support commercial change management process for serialization. Project or market dependency may be the impact assessor.
• Perform serialization data operation assessments stemming from CAPA.
• Manage daily data operational issues for commercial serialized products.
• Develop serialization operational capabilities to ensure efficiencies, robustness and sustainability.
• Reports dashboard metrics serialization data by lot, site, and markets.
• Manages technical assessment arising from Quality alert event.
• Monitor the sustainability of the technical processes already implemented.
• Remediate process to assure proper and accurate process flow of serialized data based on physical product flow.
• Propose process improvements and support implementation / execution to mitigate gaps and approve overall process robustness.
• Assures standard process for the implementation of serialization data capabilities and recommends process improvements at sites, CMOs, 3PLs and customers ensuring timely delivery, efficiency, robustness and sustainability.

Required Knowledge / Skills / Qualifications

Education: BA or BS degree in Business, supply chain management or equivalent.

Experience / Knowledge: 6-10 years total business experience, pharmaceutical manufacturing, serialization, supply chain logistics, Order to Cash experience with at least 3 yrs in data or data operation related areas. Good experience in GxP processes and systems. Solid understanding of key relationships, dependencies, and interfaces among business units, IT, and external partners. Experience in SAP or similar ERP systems and serialization systems like SAP ATTP, Trace Link etc. Good interpersonal, verbal and written communication skills. Excellent analytical and problem-solving skills to resolve data exceptions in timely manner. Ability to work in a fast-paced environment, organized and able to prioritize tasks to meet multiple deadlines.