Remediation Lead

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.

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 Quality, Manufacturing, Engineering, Maintenance, Facilities, Laboratories, Supply Chain, Regulatory Affairs, IT, Training, and Operational Excellence to remove barriers and maintain alignment.
• Strengthen investigations, root-cause analysis, CAPA design, change control, quality risk management, data integrity, and effectiveness verification to prevent recurrence and improve Quality System performance.
• Provide leadership and oversight for remediation involving sterile pharmaceutical manufacturing, aseptic processing, terminal sterilization, sterility assurance, contamination control, particulate and microbiological risk management, process validation, and equipment qualification.
• Coordinate the preparation and Quality review of regulatory responses, remediation status reports, inspection-readiness materials, leadership presentations, and supporting evidence packages.
• Ensure remediation records are complete, traceable, internally consistent, inspection-ready, and readily retrievable, with a clear linkage between identified gaps, corrective actions, implementation evidence, and effectiveness outcomes.
• Identify systemic themes, recurring failure modes, cross-workstream dependencies, and opportunities to simplify or standardize controls without weakening compliance requirements.
• Partner with functional leaders to assess resource and capability needs, sequence priorities, manage scope and change, and escalate decisions that could affect regulatory commitments, product quality, patient safety, or remediation outcomes.
• Create and monitor leading and lagging indicators such as milestone adherence, overdue-action aging, first-pass deliverable acceptance, CAPA effectiveness, recurrence, and evidence-readiness to verify that improvements are implemented and sustained.
• Coach workstream leads and subject-matter experts on clear problem definition, measurable deliverables, disciplined execution, evidence-based closure, and concise executive and regulatory communication.
• Serve as a trusted advisor to site and enterprise leadership, providing direct, objective assessments of progress, uncertainty, residual risk, and areas requiring intervention.

What You'll Bring

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, Quality, or a related technical discipline.
• At least 8 years of progressively responsible experience in pharmaceutical, biotechnology, medical device, or another highly regulated manufacturing environment, including significant experience in Quality, Compliance, or Regulatory functions.
• Demonstrated leadership of complex, cross-functional remediation, compliance, Quality System, or transformation programs involving multiple workstreams and senior stakeholders.
• Experience supporting FDA or other global health-authority inspections, regulatory responses, and remediation associated with regulatory observations, Warning Letters, OAI classifications, Consent Decrees, or comparable enforcement actions.
• Strong knowledge of cGMPs, pharmaceutical Quality Systems, investigations, CAPA, change control, quality risk management, data integrity, validation, and inspection readiness.
• Experience in sterile pharmaceutical manufacturing, including aseptic processing, sterility assurance, contamination control, injectable products, IV solutions, and/or terminal sterilization.
• Ability to critically evaluate technical and procedural content, distinguish completed activity from demonstrated effectiveness, and identify weak assumptions, insufficient controls, or unsupported closure evidence.
• Proven ability to influence without direct authority, make sound risk-based decisions, manage ambiguity, and drive accountability and follow-through across functions.
• Excellent written and verbal communication skills, including the ability to translate complex technical information into clear, decision-oriented executive and regulatory updates.
• Strong program and portfolio management discipline, including management of scope, milestones, dependencies, risks, issues, decisions, resources, and change.
• Ability to work effectively in a 24/7 regulated manufacturing environment and provide support outside standard business hours when significant quality, inspection, or remediation needs arise.
• Ability to travel as needed to support regulatory inspections, remediation activities, and enterprise governance.

Preferred Qualifications

• Master's degree in a scientific, engineering, quality, regulatory, or business discipline.
• Formal certification in project or program management, Lean Six Sigma, quality management, or change management.
• Experience leading remediation in a multi-building pharmaceutical operation or a complex sterile-manufacturing network.
• Experience with electronic Quality Management Systems, remediation portfolio dashboards, evidence repositories, and executive governance forums.
• Experience building organizational capability through coaching, leader standard work, structured problem solving, and disciplined performance management.