Manager, Quality Engineering

Baxter seeks a Manager of Quality Engineering to lead independent oversight of site validation and data integrity programs at its Round Lake facility. The role involves establishing governance, managing a technical team, ensuring regulatory compliance, and representing quality assurance to leadership and regulatory agencies.

Responsibilities

• Establish site strategy, governance model, and procedures for independent QA oversight of validation and data integrity
• Lead, develop, and performance-manage the Quality Engineering team based on project risk and business priority
• Approve validation master plans, protocols, critical deviations, and major change controls; delegate oversight as appropriate
• Chair governance forums to set risk-based priorities and resolve cross-functional conflicts across plant systems
• Represent validation and data integrity programs during FDA inspections, customer audits, and regulatory submissions

Requirements

• Bachelor's degree in Engineering, Science, Computer Science, or related technical field
• 8+ years progressive experience in validation, quality engineering, or cGMP-regulated QA with people or program leadership
• Expert knowledge of cGMP validation, GAMP 5, 21 CFR Part 11, and ALCOA+ principles
• Demonstrated ability to build and lead high-performing technical teams
• Strong strategic planning, risk-based decision-making, and cross-functional influencing skills
• Excellent written and oral communication for executive and regulatory presentations
• ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification highly desirable

Compensation: $112,000 - $154,000 base annually