Quality Engineering Manager

Baxter International Inc. • Round Lake, IL

1d • $112,000 - $154,000

About The Position

The Quality Engineering Manager leads the site quality validation program and governs the plant data integrity program. The role establishes validation strategy, quality standards, risk tolerance, and performance expectations to support compliance with regulatory and quality requirements. It partners with Engineering, Facilities, Operations, CSV, laboratories, and system owners to drive program execution while preserving independent Quality oversight through governance, review, approval, and escalation.

As the primary Quality representative for validation and data integrity, the manager interfaces with site leadership and regulatory agencies. The position also develops the Quality Engineering team and cross-functional capabilities, oversees risk-based program priorities and remediation, and represents the programs during inspections, audits, governance reviews, and regulatory submissions.

Requirements

• Bachelor’s degree in Engineering, Science, Computer Science, or a related technical field.
• Eight or more years of progressive experience in validation, quality engineering, computerized-system assurance, data integrity, or QA within a cGMP-regulated industry, including people or program leadership.
• Expert knowledge of cGMP validation, computerized-system assurance, GAMP 5, 21 CFR Part 11, ALCOA+ principles, data integrity governance, quality systems, and contemporary regulatory expectations.
• Demonstrated people leadership and ability to build high-performing technical teams.
• Capability in organizing plans, risk-informed decision-making, governance, influencing, negotiation, and conflict management.
• Ability to maintain QA independence while building effective partnerships with Engineering, Facilities, Operations, CSV, laboratories, and business leadership.
• Excellent written and oral communication skills, including executive and regulatory presentations.
• Proven success leading complex programs, inspections, remediation governance, and multifunctional organizational change.
• Working knowledge of statistics, process capability, risk-management tools, and electronic quality systems.
• Must meet all applicable site safety and occupational requirements.

Nice To Haves

• Prior experience participating in regulatory inspections and complex remediation programs.
• ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification.

Responsibilities

• Establish and maintain site strategy, governance, procedures, and decision rights for independent QA oversight of validation and plant-level data integrity.
• Lead, develop, and performance-manage the Quality Engineering team, assigning oversight according to project risk, complexity, and business priority.
• Ensure Engineering, Facilities, Operations, CSV, laboratories, and system/process owners maintain accountability for validation authoring and execution, technical operation, vulnerability remediation, and sustained control effectiveness.
• Approve or delegate approval of validation master plans, high-risk protocols and reports, critical deviations, revalidation strategies, major change controls, and continued-use or release decisions.
• Chair or sponsor validation and data integrity governance forums, set risk-based priorities across the plant system inventory, and resolve cross-functional ownership or resource conflicts.
• Ensure the data integrity program aligns with GAMP 5, 21 CFR Part 11, ALCOA+ principles, corporate standards, and current regulatory expectations.
• Review program health using metrics, audits, periodic reviews, remediation aging, deviation trends, audit-trail-review performance, and effectiveness checks; raise risks to site leadership.
• Ensure remediation plans have accountable operational owners, appropriate milestones, interim controls, documented risk acceptance, and independent QA verification of sustainable closure.
• Represent validation and data integrity programs, in partnership with system owners, during FDA and other regulatory inspections, customer audits, governance reviews, and regulatory submissions.
• Develop capability, succession plans, training, and standardized tools for Quality Engineering and cross-functional partners.
• Manage resources and continuous-improvement priorities to maintain compliant, efficient oversight without compromising QA independence.

Benefits

• Medical and dental coverage starting on day one
• Basic life, accident, short-term disability, long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan with employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program
• Childcare benefits
• May be eligible for discretionary bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Manager