Sr Mgr, Quality Systems Digital Products

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.

Communication, Change Management & Organizational Enablement

- Develop and lead the communication strategy for digital QRS initiatives, ensuring clarity, consistency, and alignment from manufacturing sites to the Global QRS Leadership Team.
- Translate technical AI capabilities and complex system changes into clear messaging tailored to executive leadership, site teams, regulatory partners, patient safety stakeholders, and cross-functional audiences.
- Own the change management approach for enterprise digital deployments, including readiness assessments, stakeholder alignment, adoption planning, and sustained post-launch support.
- Drive organizational adoption by connecting technology deployments to measurable workflow improvements and embedding change management into the product lifecycle from discovery through post-launch.

Cross-Functional & External Engagement

- Operate as the strategic connector between QRS, IT, Data Science, Supply Chain, and Manufacturing — ensuring digital solutions are designed with enterprise-wide context and adopted across organizational boundaries.
- Represent QRS’s digital transformation agenda in enterprise forums, technology governance reviews, and cross-functional strategy sessions.
- Engage with external industry organizations and regulatory bodies to maintain awareness of digital quality and regulatory trends, emerging standards, and AI governance developments that impact Baxter’s strategy.
- Lead or support continuous improvement initiatives (Kaizen, process optimization) and translate process redesign outcomes into technology-ready automation opportunities.

Education and Experience

Required

- Bachelor’s degree in a relevant field (e.g., Business, Technology, Engineering, Health Sciences, Communications, or related discipline).
- 7+ years of progressive experience spanning digital product design, enterprise systems strategy, workflow analysis, technology implementation, and cross-functional program leadership in complex or regulated environments.
- Demonstrated success designing, building, and deploying internal digital products at enterprise scale — including AI-enabled platforms, operational systems, or workflow automation solutions serving global organizations.
- Hands-on experience integrating Generative AI and machine learning capabilities into business workflows (e.g., document intelligence, automated correspondence, classification models, investigation support, and decision assistance).
- Proven ability to create and deliver enterprise-wide training and enablement programs that drive technology adoption, behavioral change, and measurable capability development across large, distributed workforces.
- Experience leading cross-functional initiatives involving engineering, Quality, Regulatory Affairs, Patient Safety, Data Science, and senior business stakeholders at the VP and Director level.
- Strong written and verbal communication skills with a demonstrated ability to translate technical and regulatory complexity into actionable guidance for diverse audiences.
- Experience developing business cases, cost-benefit analyses, and ROI frameworks that quantify enterprise system impact and justify strategic investment.

Preferred

- Executive education in business analytics, AI/ML, or digital transformation from a top-tier institution.
- Full-stack software development or engineering background with hands-on platform-building experience.
- Cloud infrastructure certification (e.g., AWS Certified Cloud Practitioner or equivalent).
- Experience in healthcare, medical device, pharmaceutical, or other highly regulated industries (FDA, ISO 13485, GxP, CMMI).
- Proficiency with Microsoft Power Platform, Copilot Studio, SharePoint, Tableau, Oracle APEX, and enterprise data visualization tools.
- Experience leading or contributing to maturity frameworks (CMMI, Six Sigma, Lean) at the enterprise level.
- Cross-industry leadership experience that brings pattern recognition, operational adaptability, and unconventional problem-solving perspectives to enterprise transformation.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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