Business System Owner

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Our Team:

Our mission is to improve manufacturing performance every day on all aspects, with priority on Safety, Quality & Compliance, and Supply. We combine Operational Excellence and Smart Factory technologies to create a connected, data-driven, and continuously improving operation. Through SMS and lean principles, digital tools, connected equipment, real-time insights, we help teams eliminate waste, solve problems faster, and deliver right-first-time quality, on time and in full. We empower employees to make better decisions through greater visibility, standardization, and automation. Together, we build a safer, smarter, and more reliable manufacturing site that consistently deliver on supply commitments to patient.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

• Own the MES and Opstrakker systems locally at the Toronto site, ensuring fit for purpose, influencing product roadmap, integration with other core models (ishift, LIMS,DowntimeIQ, other digital tools) and maintenance of the validation status
• Serve as the primary business point of contact for MES and Opstrakker at the Toronto site
• Ensure proper usage of MES and Opstrakker, being gate keeper for maintaining and increasing standardization and adherence to evolving core models, and provide required support to shop-floor end users
• Participate to system evolution and innovation, by representing the Toronto site to the MES and Opstrakker design authorities, and raising appropriate use cases

Additional responsibilities:

• Serve as the accountable business authority for requirements definition and validation across the MES and Opstrakker lifecycle. Ensure that business needs are accurately captured, correctly translated into functional specifications, and formally verified at each lifecycle gate; from initial URS authoring through change control and system evolution, n line with GMP, 21 CFR Part 11 and CSV (IQ/OQ/PQ) expectations
• Assess and provide business approval for change requests impacting system functionality, configuration, or integrations
• Manage user access governance and associated training requirements
• Coordinate periodic reviews and re-validation activities per site procedures
• Assess business impact of system incidents, deviations, and CAPAs
• Monitor and report system performance KPIs (availability, data integrity, adoption)
• Support Sanofi’s digital transformation programs, specifically MES/eBMR (electronic batch records), Opstrakker, coordinating implementation activities and ensuring alignment across Manufacturing, Quality, Supply Chain and Digital.
• Coordinate with Business Process Owners (BPOs) in Manufacturing, Quality and Supply Chain to implement core model adherence and drive shop-floor process improvements.
• Ensure compliance with Sanofi standards, GMP, 21 CFR Part 11, data integrity (ALCOA+) and site procedures for computerized systems.
• System Evolution & Roadmap: Identify, assess, and prioritize MES and Opstrakker enhancements based on operational needs and value delivery, Build business cases for upgrades, new modules, or integrations (e.g., MES–SAP, MES–LIMS, Opstrakker–PiVision/DowntimeIQ), Co-develop system roadmap with Digital partners in alignment with Smart Factory strategy and the Sanofi Shine methodology, Support annual budget planning for the assigned system portfolio

About You

Qualification and Experience:

• Bachelor’s degree in Science, Engineering (Chemical, Industrial, Manufacturing, Mechanical, or related field), Computer Science, Information Systems, or equivalent technical discipline
• Minimum 3+ years of experience in pharmaceutical or biopharmaceutical manufacturing operations or equivalent industries
• Hands‑on experience with MES platforms (e.g., Werum PAS‑X, Rockwell or equivalent) and shop‑floor performance/OEE solutions (Opstrakker, or comparable)
• Working knowledge of GMP, 21 CFR Part 11, computer system validation (CSV IQ/OQ/PQ), electronic batch records (eBMR) and data integrity (ALCOA+)
• Proven project management experience, including leading cross‑functional digital transformation initiatives

What Success Looks Like in This Role:

• MES and Opstrakker a