Business System Owner - GxP

Role Summary

Local Business System Owner (BSO) responsible for Swiftwater site implementation, lifecycle, and compliance with global Smart Factory solutions that support Manufacturing & Supply operations. Reports to the Swiftwater Smart Factory Head and drives digital innovation and modernization at the site level while aligning with global strategies, processes, and core models. Hybrid role - 4 days a week onsite.

Responsibilities

• Governance & Compliance: Ensure alignment of site procedures and practices with Sanofi Global Quality Documents; gatekeeper for local system adherence including audit trail review, user access control, and local application of business procedures; represent the site with Quality, Digital, and Business functions (site and global).
• System Ownership: Maintain the validated state of the Sanofi Smart Factory System at the site level; ensure the system remains fit-for-purpose and aligned with evolving core models and business needs.
• System Use & Support: Ensure system usage meets business needs and supports operational efficiency; provide training and support to end users; lead the network of key users and provide Level 2 and Level 3 support.
• Innovation & Roadmap: Initiate local use cases and communicate site-specific pain points to the global team; drive business activities related to solution implementation initiatives; manage Business Value Projects, Major and Minor releases, Legacy System Decommissioning; represent the site in design authority and participate in roadmap discussions to ensure alignment with global direction.
• Collaboration Focus: Collaborate with the site Smart Factory Head, global BSO, and other stakeholders to ensure local needs are represented and aligned with global strategy.
• Quality Management: Manage deviations, CAPAs, change control, documentation, training, audit trail reviews, access management, and business continuity; investigate and resolve incidents related to the system; participate in local qualification phases and contribute to audits and inspections.
• Resource & Budget Management: Define and allocate resources and budgets for system evolution projects and maintenance; plan system-related activities and provide visibility on priorities.
• Documentation, Processes & Support: Review and approve local documentation related to system configuration, design, and operations; support users in adopting digital solutions and ensure proper documentation and training are in place.
• Change Management: Support users in adopting digital solutions; develop a change plan for the business transformation; develop and execute communication plans to site and global stakeholders; drive continuous improvement for Smart Factory solutions through collaboration with Manufacturing Standards & Area Process areas.

Qualifications

• Education: Bachelor’s Degree in Engineering, Life or Data Sciences or related discipline preferred; combination of education and experience will be considered.
• Experience: 5+ years in Pharmaceutical Industry, Computerized System implementation or Project Management preferred; GxP and Data Integrity knowledge required.
• Preferred: Led project teams; Continuous Improvement and Service Level Management (SLA) related to Incident Management; Risk Assessment; experience with SAP, Siemens, Veeva, Power BI.