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) with company match

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO 20–35 days

Commuting benefits

Job summary

Baxter International Inc. is seeking a Quality Engineering Manager to lead the Quality Engineering function, overseeing site validation and data integrity programs.

You will set strategy, standards, and governance, and partner with Engineering, Facilities, Operations, CSV, labs, and system owners to ensure compliant program execution. You will interface with site leadership and regulators, ensuring validation activities are executed with accountability and independent QA oversight.

Qualifications

• Expert knowledge of cGMP validation, computerized-system assurance, GAMP 5, 21 CFR Part 11, ALCOA+ principles, data integrity governance, quality systems, and contemporary regulatory expectations.
• Demonstrated people leadership and ability to build high-performing technical teams.
• Proven capability in organizing plans, making decisions considering risks, governance, influencing, negotiation, and managing conflicts.
• Ability to maintain QA independence while creating effective partnerships with Engineering, Facilities, Operations, CSV, laboratories, and business leadership.
• Excellent written and oral communication skills, including executive and regulatory presentations.
• Proven success leading complex programs, inspections, remediation governance, and multi-functional organizational change.
• Working knowledge of statistics, process capability, risk-management tools, and electronic quality systems.

Responsibilities

• Establish and maintain the site strategy, governance model, procedures, and decision rights for independent QA oversight of validation and plant-level data integrity.
• Lead, develop, and performance-manage the Quality Engineering team; assign oversight based on project risk, complexity, and business priority.
• Ensure Engineering, Facilities, Operations, CSV, laboratories, and system/process owners maintain clear accountability for validation authoring and execution, technical operation, vulnerability remediation, and sustained control effectiveness.
• Approve or delegate approval of validation master plans, high-risk protocols and reports, critical deviations, revalidation strategies, major change controls, and continued use or release decisions.
• Chair or sponsor validation and data integrity governance forums; set risk-based priorities across the plant system inventory and resolve multi-functional ownership or resource conflicts.
• Ensure the data integrity program is aligned with GAMP 5, 21 CFR Part 11, ALCOA+ principles, corporate standards, and current regulatory expectations.
• Review program health through metrics, audits, periodic reviews, remediation aging, deviation trends, audit-trail-review performance, and effectiveness checks; raise risks to site leadership.
• Ensure remediation plans have accountable operational owners, appropriate milestones, interim controls, documented risk acceptance, and independent QA verification of sustainable closure.
• Represent validation and data integrity programs, in partnership with system owners, during FDA and other regulatory inspections, customer audits, governance reviews, and regulatory submissions.
• Develop capability, succession plans, training, and standardized tools for Quality Engineering and multi-functional partners.
• Manage resources and continuous-improvement priorities to maintain compliant, efficient oversight without compromising QA independence.

Skills

cGMP validation

GAMP 5

data integrity

quality systems

regulatory expectations

leadership

Education

Bachelor’s degree in Engineering, Science, CS

ASQ CQE/CSQE/CQA certification desirable

Job description

Baxter International Inc. is seeking a Quality Engineering Manager to lead the Quality Engineering function, overseeing site validation and data integrity programs.

You will set strategy, standards, and governance, and partner with Engineering, Facilities, Operations, CSV, labs, and system owners to ensure compliant program execution. You will interface with site leadership and regulators, ensuring validation activities are executed with accountability and independent QA oversight.