Manager, Quality Engineering
Baxter International Inc.
Summary
Leads the Quality Engineering function responsible for independent oversight of the site validation program and governance of the plant data integrity program. Sets strategy, standards, risk tolerance, and performance expectations; ensures effective QA partnership with Engineering, Facilities, Operations, CSV, laboratories, and system owners; and represents the QA oversight of these programs to site leadership and regulatory agencies. The manager ensures accountable owners execute validation and remediation work while Quality Engineering personnel maintain independent review, approval, escalation, and governance.
Job description
Essential Duties and Responsibilities
- Establish and maintain the site strategy, governance model, procedures, and decision rights for independent QA oversight of validation and plant-level data integrity.
- Lead, develop, and performance-manage the Quality Engineering team; assign oversight based on project risk, complexity, and business priority.
- Ensure Engineering, Facilities, Operations, CSV, laboratories, and system/process owners maintain clear 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 is aligned with GAMP 5, 21 CFR Part 11, ALCOA+ principles, corporate standards, and current regulatory expectations.
- Review program health through metrics, audits, periodic reviews, remediation aging, deviation trends, audit-trail-review performance, and effectiveness checks; escalate 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.
Qualifications
- 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.
- Strong strategic planning, risk-based decision-making, governance, influencing, negotiation, and conflict-resolution skills.
- Ability to maintain QA independence while creating 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 cross-functional organizational change.
- Working knowledge of statistics, process capability, risk-management tools, and electronic quality systems.
- Candidate must meet all applicable site safety and occupational requirements.
Education and/or Experience
- Bachelor’s degree in Engineering, Science, Computer Science, or a related technical discipline required.
- 8 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.
- Prior experience participating in regulatory inspections and complex remediation programs desired.
- ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification highly desirable.
Requirements
- Bachelor’s degree in Engineering, Science, Computer Science, or a related technical discipline required
- 8 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
- Strong strategic planning, risk-based decision-making, governance, influencing, negotiation, and conflict-resolution skills
- Ability to maintain QA independence while creating 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 cross-functional organizational change
- Working knowledge of statistics, process capability, risk-management tools, and electronic quality systems
- Candidate must meet all applicable site safety and occupational requirements
- Prior experience participating in regulatory inspections and complex remediation programs desired
- ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification highly desirable
Benefits
- Medical, Dental & Vision
- Life Insurance
- Accident Insurance
- Short & Long-Term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family & Medical Leave
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.