Quality Engineering Manager

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

You will lead the quality validation program and governance of the plant data integrity program. This role establishes validation strategy, quality standards, risk tolerance, and performance expectations to ensure compliance with regulatory and quality requirements. You will partner closely with Engineering, Facilities, Operations, CSV, laboratories, and system owners to drive effective program execution.

As the primary Quality representative for validation and data integrity, you will interface with site leadership and regulatory agencies. The Quality Engineering Manager ensures validation and remediation activities are executed by accountable owners while maintaining independent Quality oversight through governance, review, approval, and escalation.

Essential Duties and 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.

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.
• Candidate must meet all applicable site safety and occupational requirements.

Education and/or Experience:

• Bachelor’s degree in Engineering, Science, Computer Science, or a related technical field required.
• 8 or more years of progressive experience in validation, quality engineering, computerized-system assurance, data integrity, or QA within a cGMP-regulated industry, including people or program leadership.
• Prior experience participating in regulatory inspections and complex remediation programs desired.
• ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification highly desirable.

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