Quality Engineering Manager: Validation & Data Integrity

Baxter International Inc.; Round Lake (IL); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee stock purchase plan

Paid time off

Job summary

Baxter International Inc. is seeking a Quality Engineering Manager to lead the site validation program and oversee data integrity governance. You will collaborate with Engineering, Facilities, Operations, CSV, laboratories, and system owners to ensure compliant and high-quality outcomes.

You will interface with site leadership and regulators, driving independent QA oversight, approving master plans and change controls, and guiding remediation activities to ensure timely, effective resolution.

Qualifications

• Expert knowledge of cGMP validation and data integrity governance.
• Proven leadership to build high-performing technical teams.
• Experience with regulatory inspections and remediation programs.
• Strong communication and stakeholder management.

Responsibilities

• Establish and maintain site strategy, governance model, procedures, and QA oversight of validation and data integrity.
• Lead, develop, and performance-manage the Quality Engineering team.
• Ensure accountability across engineering, facilities, operations, CSV, labs, and system owners.
• Approve validation master plans, high-risk protocols and reports, deviations, and change controls.
• Chair validation and data integrity governance forums; set risk-based priorities.
• Ensure data integrity program aligns with GAMP 5, 21 CFR Part 11, ALCOA+ and regulatory expectations.
• Review program health through metrics, audits, and remediation aging.
• Represent validation programs during FDA inspections and regulatory submissions.
• Develop capability, succession plans, training, and standardized tools.
• Manage resources and continuous-improvement priorities while maintaining QA independence.

Skills

cGMP validation

computerized-system assurance

GAMP 5

21 CFR Part 11

ALCOA+ principles

data integrity governance

quality systems

regulatory expectations

Education

Bachelor’s degree in Engineering, Science, Computer Science, or related field

ASQ CQE, CSQE, CQA, Six Sigma or comparable certification

Job description

Baxter International Inc. is seeking a Quality Engineering Manager to lead the site validation program and oversee data integrity governance. You will collaborate with Engineering, Facilities, Operations, CSV, laboratories, and system owners to ensure compliant and high-quality outcomes.

You will interface with site leadership and regulators, driving independent QA oversight, approving master plans and change controls, and guiding remediation activities to ensure timely, effective resolution.