Quality Validation & Data Integrity Lead

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

Job summary

Baxter International Inc. in Round Lake, IL is seeking a Quality Engineering Manager to lead the validation and data integrity program. You will partner with Engineering, Facilities, Operations, CSV, laboratories, and system owners to drive effective program execution and independent QA oversight.

The role focuses on governance, risk management, and ensuring compliance with GAMP 5, 21 CFR Part 11, and ALCOA+ principles, while preparing for regulatory inspections and audits.

Qualifications

• Bachelor’s degree in Engineering, Science, Computer Science, or a related technical field.
• 8+ years in validation, quality engineering, computerized-system assurance, data integrity, or QA.
• ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification highly desirable.

Responsibilities

• Establish validation governance for 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 or delegate validation master plans, high-risk protocols, reports, deviations, and changes.
• Chair validation and data integrity governance forums; set risk-based priorities.
• Align data integrity program with GAMP 5, 21 CFR Part 11, ALCOA+ principles and regs.
• Review program health via metrics, audits, and remediation trends.
• Ensure remediation plans have accountable owners and QA verification.
• Represent programs during FDA inspections, audits, and regulatory reviews.
• Develop capability, succession plans, training, and standardized tools.
• Manage resources to maintain compliant, efficient QA oversight.

Skills

cGMP validation

GAMP 5

21 CFR Part 11

data integrity

leadership

communication

Education

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

8+ years in validation, quality engineering, or data integrity

ASQ CQE/CSQE/CQA or Six Sigma desirable

Job description

Baxter International Inc. in Round Lake, IL is seeking a Quality Engineering Manager to lead the validation and data integrity program. You will partner with Engineering, Facilities, Operations, CSV, laboratories, and system owners to drive effective program execution and independent QA oversight.

The role focuses on governance, risk management, and ensuring compliance with GAMP 5, 21 CFR Part 11, and ALCOA+ principles, while preparing for regulatory inspections and audits.