
Sr Mgr, Quality Systems Digital Products Guadalajara, Jalisco
Baxter · Guadalajara, Jalisco, 45116 Zapopan
Job description
Overview This is where we value your strategic mindset, technical expertise and passion for innovation. If you are someone who has the ability to transform strategies into actionable plans while also demonstrating empathy and a willingness to assist others, this might be the right opportunity for you. Your contributions will make a significant impact on Baxter's mission to save and sustain lives. Paid Time Off Employee Health & Well-Being Benefits Continuing Education/ Professional Development Support for Parents Employee Assistance Program Success Profile What makes a successful Information Technology team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit. Strategic Business Partner Communicator Curious Results driven Collaborative Problem Solver Sr Mgr, Quality Systems Digital Products Apply Now This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. The Senior Manager, AI Strategy & Enterprise QRS Systems is responsible for leading the strategy, design, development, and enterprise deployment of AI-enabled platforms and digital systems across Baxter’s Quality, Regulatory, and Patient Safety organization. This role owns the identification of operational inefficiencies, compliance gaps, and process fragmentation across QRS functions and translates those findings into scalable digital solutions that serve the global network. This role operates across Quality, Regulatory Affairs, Patient Safety, Manufacturing, Supply Chain, IT, and Data Science — functioning as the primary bridge between QRS business needs and technology execution. The role owns the full product lifecycle of multiple enterprise systems simultaneously, from discovery and feasibility through architecture, build, validation, deployment, training, adoption, and continuous improvement. Responsibilities include AI solution design, build-versus-buy evaluation, vendor assessment, product architecture definition, enterprise application development and maintenance, and system readiness for global deployment in regulated environments. This role also owns the organization’s Digital & AI Fluency Program — an enterprise initiative that equips QRS professionals with the skills, frameworks, and tools to apply AI, automation, and modern digital capabilities in their daily work. This dual responsibility — building enterprise systems and building workforce capability — defines the scope and strategic position of this role within the QRS organization. This position directly supports operational excellence, enterprise digital transformation, and Baxter’s mission to save and sustain lives. Essential Duties and Responsibilities Enterprise AI & Digital Strategy Lead the end-to-end strategy, roadmap, and delivery of AI-enabled digital solutions across the QRS organization — spanning quality operations, regulatory intelligence, audit readiness, investigation management, document governance, post-market surveillance, patient safety reporting, supplier oversight, and workforce enablement. Identify operational inefficiencies, compliance risks, and process fragmentation across Quality, Regulatory Affairs, and Patient Safety functions by working directly with QRS leaders, site teams, and cross-functional partners — then translate those findings into enterprise-grade digital solutions. Define product vision and system architecture in partnership with IT engineering, Data Science, and enterprise technology teams to ensure scalability, regulatory compliance, integration readiness, and long-term sustainability. Own build-versus-buy decisions by evaluating feasibility, total cost of ownership, compliance requirements, user experience, vendor capabilities, and strategic alignment. Create comprehensive business cases and cost-benefit analyses for new capabilities, quantifying impact on cycle time, labor efficiency, risk mitigation, and enterprise value creation. Conduct vendor evaluations (RFI/RFP) for potential third-party solutions and coordinate across Legal, Procurement, Digital, IT, and QRS stakeholders. Enterprise Platform Design, Development & Lifecycle Management Design, build, deploy, and maintain multiple concurrent enterprise digital platforms serving global Quality, Regulatory, and Patient Safety operations across all manufacturing and CQARA sites globally. Manage the full product lifecycle from discovery and feasibility through architecture, build, validation, launch, adoption, and continuous improvement — ensuring alignment with regulatory priorities, patient safety imperatives, business strategy, and user needs. Translate complex, multi-step QRS workflows into end-to-end digital solutions that reduce manual effort, improve documentation quality, strengthen compliance posture, and accelerate decision-making across functions. Architect and deploy AI agents, intelligent automation, and machine learning solutions using LLMs, NLP, OCR, document intelligence, and Microsoft Copilot Studio to address high-volume, high-impact QRS processes at scale. Ensure all digital and AI solutions are designed with appropriate guardrails for regulatory compliance, data integrity, auditability, and responsible use in GxP environments. Partner with site Quality leaders, Regulatory Affairs teams, Patient Safety stakeholders, QMRs, and plant leadership to ground every platform in operational reality — ensuring solutions are practical, adoption-ready, and built to address documented process needs. AI Innovation & Responsible AI Adoption Serve as the organization’s primary AI subject matter expert, advising QRS leadership, IT, and cross-functional partners on practical AI applications, emerging capabilities, and strategic opportunities. Lead the integration of Generative AI capabilities into enterprise QRS workflows, including automated document intelligence, regulatory impact analysis, investigation assistance, compliance scoring, trend detection, and intelligent correspondence generation. Ensure responsible AI governance by embedding compliance, auditability, and data integrity standards into every AI solution from design through deployment. Contribute to and advise on enterprise-wide AI initiatives, strengthening alignment between IT infrastructure and QRS’s AI adoption roadmap. Digital & AI Fluency Program Ownership Own the design, delivery, and continuous evolution of Baxter’s Digital & AI Fluency Program — the enterprise initiative that equips QRS professionals with the skills, frameworks, and confidence to apply AI, automation, and modern digital tools in their daily work. Develop role-based learning paths, automation libraries, scenario-based training, and hands-on workshops that connect digital tools to real QRS workflows and measurable outcomes. Deliver training sessions, AI Office Hours, and direct coaching to build capability across all levels — from site QA/QC and regulatory professionals to QRS leadership — fostering a culture of continuous learning and digital adoption. Design measurement frameworks including baseline assessments, adoption metrics, and behavior-change indicators to demonstrate program ROI and inform ongoing investment. Partner with HR, L&D, and enterprise learning platforms to integrate fluency pathways into existing talent development infrastructure.
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