Quality Engineering Manager

Baxter•Round Lake, IL

18h

About The Position

The Quality Engineering Manager leads the plant quality validation program and governs plant-level data integrity. The role establishes validation strategy, quality standards, risk tolerance, and performance expectations to support regulatory and quality compliance. It partners with Engineering, Facilities, Operations, CSV, laboratories, and system owners to drive execution, while serving as the primary Quality representative for validation and data integrity with site leadership and regulatory agencies. The manager ensures accountable owners execute validation and remediation activities while Quality provides independent oversight through governance, review, approval, and escalation. The role leads and develops the Quality Engineering team, sets risk-based oversight priorities, and sponsors governance forums. It maintains alignment with GAMP 5, 21 CFR Part 11, ALCOA+ principles, corporate standards, and current regulatory expectations. The manager monitors program health, escalates risks, oversees remediation governance and sustainable closure, and represents the programs during inspections, audits, governance reviews, and regulatory submissions. The position also develops team and partner capabilities, manages resources, and drives continuous improvement without compromising QA independence.

Requirements

Bachelor’s degree in Engineering, Science, Computer Science, or a related technical field.
Eight 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.
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.
Ability to organize plans, make risk-informed decisions, lead governance, influence and negotiate, and manage conflicts.
Ability to maintain QA independence while building 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 cross-functional organizational change.
Working knowledge of statistics, process capability, risk-management tools, and electronic quality systems.
Must meet all applicable site safety and occupational requirements.

Nice To Haves

Prior experience participating in regulatory inspections and complex remediation programs.
ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification.

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, assigning oversight based on project risk, complexity, and business priority.
Ensure Engineering, Facilities, Operations, CSV, laboratories, and system/process owners maintain 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 cross-functional ownership or resource conflicts.
Ensure the data integrity program aligns with GAMP 5, 21 CFR Part 11, ALCOA+ principles, corporate standards, and current regulatory expectations.
Review program health using 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 cross-functional partners.
Manage resources and continuous-improvement priorities to maintain compliant, efficient oversight without compromising QA independence.

Benefits

Medical and dental coverage starting on day one.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contributions and company matching.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence.
Paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program.
Childcare benefits.
Potential eligibility for discretionary bonuses.