Quality Engineering Lead: Validation & Data Integrity

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

Benefits offered by this job

Health insurance

401(k) Retirement Plan

Employee Stock Purchase Plan (ESPP)

Job summary

Baxter is seeking a Quality Engineering Manager to lead the QA oversight of validation and plant data integrity programs at our Illinois site. You will shape strategy, standards, risk tolerance, and performance expectations to ensure regulatory compliance and quality system integrity.

You will partner with Engineering, Facilities, Operations, CSV, and laboratories to drive effective program execution, approvals, and governance across the site.

Qualifications

• Expert knowledge of cGMP validation and data integrity governance.
• Proven ability to lead technical teams and manage programs.
• Experience with regulatory inspections and complex remediation.
• ASQ CQE/CSQE/CQA or Six Sigma certification desirable.

Responsibilities

• Establish site strategy and QA governance for validation and data integrity.
• Lead Quality Engineering team and assign oversight by project risk.
• Ensure accountability for validation authoring, execution, and remediation.
• Chair validation and data integrity governance forums.
• Represent QA in FDA inspections and regulatory submissions.
• Develop training and standardized tools for QA and partners.
• Balance resources to maintain independent QA oversight.

Skills

QA leadership

Regulatory knowledge

Data integrity governance

CFR compliance

Communication skills

Audit readiness

Education

Bachelor's degree

ASQ CQE/CSQE/CQA/Six Sigma

Job description

Baxter is seeking a Quality Engineering Manager to lead the QA oversight of validation and plant data integrity programs at our Illinois site. You will shape strategy, standards, risk tolerance, and performance expectations to ensure regulatory compliance and quality system integrity.

You will partner with Engineering, Facilities, Operations, CSV, and laboratories to drive effective program execution, approvals, and governance across the site.