Remediation Lead

Req # 212922 Location Round Lake, Illinois, United States Job Category Quality Date posted 11/09/2026 Overview This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. Support for Parents Continuing Education/ Professional Development Employee Health & Well-Being Benefits Paid Time Off 2 Days a Year to Volunteer Success Profile What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit. Detail Oriented Continuous Learner Courageous Collaborative Critical Thinker Influential 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. Your Role at Baxter As the Remediation Lead, you will provide senior Quality leadership for the design, integration, and execution of complex remediation programs at Round Lake Drug Delivery. You will translate regulatory observations, inspection findings, quality-system gaps, and internal commitments into practical, risk-based plans that deliver sustainable compliance, protect product quality, and support patient safety. You will serve as the single point of integration across remediation workstreams, establishing disciplined governance, clarifying accountability, managing interdependencies, and providing transparent, fact-based reporting to site and enterprise leadership. You will partner closely with Quality, Manufacturing, Engineering, Laboratories, Supply Chain, Regulatory Affairs, IT, and other functions while preserving the technical accountability of process owners and subject-matter experts. This role is ideal for an experienced Quality leader who combines deep pharmaceutical compliance knowledge with strong program leadership, sound regulatory judgment, and a demonstrated ability to drive complex work to evidence-based and sustainable closure. What You'll Be Doing Lead the development, integration, and execution of site remediation strategies arising from regulatory inspections, Warning Letters, OAI classifications, health-authority commitments, audits, quality-system assessments, and significant recurring quality signals. Translate commitments and identified gaps into clearly defined workstreams, accountable owners, milestones, dependencies, deliverables, interim controls, effectiveness measures, and objective closure evidence. Establish and maintain a risk-based remediation master plan and governance cadence that provides clear visibility to progress, overdue actions, critical-path constraints, resource needs, decision requirements, and emerging risks. Provide independent Quality oversight and constructive challenge to ensure remediation plans are technically sound, scientifically justified, regulatorily defensible, feasible, and aligned with commitments made to health authorities and internal governance bodies. Drive cross-functional execution across…

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