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
Manager, Quality Engineering in round lake at Unknown Company
This position is listed as full time and onsite.