Senior 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

Medical and dental coverage from day 1

401(k) Retirement Savings Plan

Paid time off 20–35 days

Job summary

Baxter International Inc. in the United States seeks a Quality Engineering Manager to lead validation and data integrity governance across the plant.

You will drive strategy, partner with Engineering, Facilities, Operations, CSV, laboratories, and system owners to ensure effective program execution. You will interface with site leadership and regulatory agencies, maintaining QA independence while enabling cross-functional collaboration.

Qualifications

• Expert knowledge of cGMP validation, GAMP 5, 21 CFR Part 11, ALCOA+ principles.
• 8+ years of progressive experience in validation, quality engineering, data integrity, or QA within a cGMP-regulated industry.
• Proven leadership experience building high-performing technical teams.
• Experience participating in regulatory inspections and remediation programs.
• ASQ CQE, CSQE, CQA, Six Sigma or similar certification is highly desirable.

Responsibilities

• Establish and maintain site strategy, governance, and QA oversight for validation and data integrity.
• Lead, develop, and performance-manage the Quality Engineering team and assign oversight by risk and priority.
• Ensure clear accountability across owners for validation, execution, and remediation activities.
• Approve or delegate validation master plans, high-risk protocols, deviations, and release decisions.
• Chair governance forums and set risk-based priorities for plant system inventory.
• Ensure data integrity program aligns with regulatory expectations and ALCOA+.
• Represent programs during FDA inspections, customer audits, and regulatory submissions.
• Develop capability, succession, and standardized tools for QA and multi-functional partners.

Skills

cGMP validation

Quality engineering leadership

Data integrity governance

Regulatory inspections experience

Executive/regulatory presentations

Education

Bachelor’s degree in Engineering/Science/CS

Job description

Baxter International Inc. in the United States seeks a Quality Engineering Manager to lead validation and data integrity governance across the plant.

You will drive strategy, partner with Engineering, Facilities, Operations, CSV, laboratories, and system owners to ensure effective program execution. You will interface with site leadership and regulatory agencies, maintaining QA independence while enabling cross-functional collaboration.