Manager, Quality Engineering

Baxter Healthcare; Town of Round Lake (WI); On-site; USD 112,000 - 154,000; Full time

Job summary

Baxter Healthcare in Round Lake, IL is seeking a Quality Engineering Manager to oversee the site validation program and data integrity governance. You will set strategy, standards, and risk tolerance, partnering with Engineering, Facilities, Operations, CSV, and laboratories to ensure compliance and effective program execution.

As the primary Quality representative for validation and data integrity, you will lead a team, approve master plans and change controls, and chair governance forums,

Qualifications

• Expert knowledge of cGMP validation, GAMP 5, 21 CFR Part 11, ALCOA+ principles, data integrity governance
• Demonstrated people leadership and ability to build high-performing technical teams
• Proven capability in organizing plans, governance, and risk-based decision making

Responsibilities

• Establish site strategy and governance for QA oversight of validation and data integrity.
• Lead, develop, and performance-manage the Quality Engineering team; assign oversight by risk and priority.
• Ensure accountability for validation authoring, execution, and remediation; maintain QA independence.

Skills

Quality leadership

Regulatory compliance

Risk management

Effective communication

Independent QA oversight

Education

Bachelor’s degree in Engineering/Science/CS

ASQ CQE/CSQE/CQA certification desirable

Job description

This is whereyour 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.

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.
Summary:

You will lead the Quality Engineering function, providing independent oversight of the site validation program and governance of the plant data integrity program. The Quality Engineering Manager establishes strategy, standards, risk tolerance, and performance expectations to ensure compliance with regulatory and quality requirements. You will build strong partnerships with Engineering, Facilities, Operations, CSV, laboratories, and system owners to support effective program execution.

As the primary Quality representative for validation and data integrity programs, 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 review, approval, escalation, and governance.

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.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice
Recruitment Fraud Notice. Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

25212 W Illinois Route 120 RL/Drug|Round Lake, IL 60073|United States of America