Quality Validation & Data Integrity Manager

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

Benefits offered by this job

Discretionary bonuses

Job summary

Baxter is seeking a Quality Engineering Manager in Illinois to lead the validation and data integrity programs across plant operations. You will partner with Engineering, Facilities, CSV, laboratories, and system owners to ensure compliance with regulatory and quality requirements.

The role requires directing a high-performing Quality Engineering team, maintaining QA independence, and driving remediation with accountable owners.

Qualifications

• Expert knowledge of cGMP validation and data integrity governance.
• Familiarity with regulatory expectations and QA independence.

Responsibilities

• Establish site validation governance and QA oversight for validation and data integrity.
• Lead, develop, and performance-manage the Quality Engineering team.
• Ensure accountability across system owners for validation execution and remediation.
• Approve major validation plans, deviations, and release decisions.
• Chair governance forums and set risk-based priorities for the plant system inventory.
• Align the data integrity program with GAMP 5, 21 CFR Part 11, and ALCOA+.

Skills

cGMP validation

GAMP 5

21 CFR Part 11

ALCOA+

data integrity governance

leadership

communication

risk management

statistics

Education

Bachelor's degree in Engineering/Science/CS

ASQ CQE/CSQE/CQA certification desirable

Job description

Baxter is seeking a Quality Engineering Manager in Illinois to lead the validation and data integrity programs across plant operations. You will partner with Engineering, Facilities, CSV, laboratories, and system owners to ensure compliance with regulatory and quality requirements.

The role requires directing a high-performing Quality Engineering team, maintaining QA independence, and driving remediation with accountable owners.