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 insurance

401(k) plan

Paid holidays & PTO

Job summary

Baxter International Inc. is seeking a Quality Engineering Manager to lead the QA oversight of validation and data integrity programs at the Round Lake site.

You will set strategy, uphold ALCOA+ principles, and partner with Engineering, Facilities, Operations, CSV, and laboratories to ensure compliant, efficient program execution. You will represent QA during FDA inspections, drive governance forums, and mentor a high-performing team, ensuring independent QA oversight while enabling

Qualifications

• Expert knowledge of cGMP validation and data integrity.
• Proven leadership of technical teams and programs.
• Experience with FDA inspections and remediation governance.

Responsibilities

• Establish site strategy and governance for QA oversight of validation and data integrity.
• Lead Quality Engineering team and allocate oversight based on risk and priority.
• Ensure accountability for validation authoring, execution, and remediation with independent QA verification.
• Interface with site leadership and regulatory agencies during inspections and audits.

Skills

QA leadership

GAMP 5

Data integrity

Education

Engineering/Science degree

ASQ CQE certification

Job description

Baxter International Inc. is seeking a Quality Engineering Manager to lead the QA oversight of validation and data integrity programs at the Round Lake site.

You will set strategy, uphold ALCOA+ principles, and partner with Engineering, Facilities, Operations, CSV, and laboratories to ensure compliant, efficient program execution. You will represent QA during FDA inspections, drive governance forums, and mentor a high-performing team, ensuring independent QA oversight while enabling