Manager, QMS

Baxter; Round Lake Beach (IL); Presencial; USD 112.000 - 154.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) with company match

Employee stock purchase plan (ESPP)

Descripción de la vacante

Baxter is seeking a Quality Management System Program Leader in Illinois to oversee essential quality programs and governance across investigations, complaints, and change control. You will lead a high-visibility team, drive risk-based improvements, and sustain inspection readiness in a regulated manufacturing environment.

The role emphasizes collaboration with manufacturing, engineering, and regulatory affairs, with a focus on data-driven decisions, CAPA implementation, and continuous quality

Formación

• 8+ years in Quality, regulated manufacturing, or similar environments.
• 3+ years of leadership managing people and cross-functional quality initiatives.
• Experience with cGMP, quality governance, investigations, CAPA, change control, and data integrity.
• Regulatory inspection readiness experience and presenting quality performance to leadership.
• Ability to analyze complex data and translate insights into actions for improvement.

Responsabilidades

• Lead the site Quality Management System portfolio, overseeing investigations, customer complaints, change control, APQR, and management reviews.
• Establish governance frameworks, performance measures, escalation processes, and risk-based priorities.
• Drive analysis of quality data and trends to identify risks, recurring issues, and preventive actions.
• Partner with Manufacturing, Engineering, Regulatory Affairs, and other functions to ensure timely, evidence-based decisions.
• Develop and coach Quality professionals and foster accountability and continuous improvement.
• Monitor quality performance with scorecards and reporting to improve process health and outcomes.
• Represent quality during internal audits, customer assessments, and regulatory inspections.

Conocimientos

Quality leadership

Regulatory compliance

cGMP knowledge

Data analysis

Cross-functional collaboration

Audit readiness

Risk management

Leadership

Educación

Bachelor's degree

Herramientas

TrackWise

Power BI

Tableau

Smartsheet

Excel

Descripción del empleo

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.

Your Role at Baxter

As the Quality Management System (QMS) Program Leader, you will oversee a portfolio of quality system programs that are essential to maintaining product quality, regulatory compliance, and operational excellence. You will serve as the site leader for investigation management while providing governance and strategic direction across customer complaints, change control, APQR, and management review processes.

In this highly visible leadership role, you will establish effective quality governance, strengthen organizational accountability, develop high-performing teams, and ensure risks are identified, evaluated, and addressed proactively. Success will be measured through improved process performance, inspection readiness, data-driven decision making, and the sustained effectiveness of quality systems that support patients, customers, and business objectives.

What You'll Be Doing

• Lead the site Quality Management System portfolio, providing oversight of investigations, customer complaints, change control, APQR, management review, and related quality programs.
• Establish governance frameworks, performance measures, escalation processes, and risk-based priorities that strengthen compliance and operational effectiveness.
• Drive meaningful analysis of quality data and trends to identify emerging risks, recurring issues, systemic opportunities, and preventive actions across the business.
• Partner with Manufacturing, Engineering, Quality Control, Regulatory Affairs, Validation, Supplier Quality, and other cross-functional teams to ensure timely, evidence-based decisions and sustainable solutions.
• Develop and coach Quality professionals while fostering accountability, capability growth, and a culture of continuous improvement.
• Monitor quality performance through integrated scorecards and reporting, using metrics to improve process health, effectiveness, and organizational outcomes.
• Represent quality system programs during internal audits, customer assessments, and regulatory inspections while maintaining ongoing inspection readiness.

What You'll Bring

Required Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline.
• 8+ years of progressive experience in Quality, regulated manufacturing, compliance, laboratory operations, engineering, product surveillance, or similar environments within pharmaceutical, biotechnology, medical device, or other highly regulated industries.
• 3+ years of leadership experience managing people, leading quality programs, or directing significant cross-functional quality initiatives.
• Demonstrated expertise in cGMP regulations, quality system governance, investigations, CAPA, customer complaints, change control, quality risk management, and data integrity principles.
• Proven ability to analyze complex quality data, identify trends, assess risk, and translate insights into business decisions and continuous improvement actions.
• Experience leading regulatory inspection readiness activities and presenting quality performance, risks, and recommendations to senior leadership.

Preferred Qualifications

• Advanced degree in a scientific, engineering, quality, or related discipline.
• Experience leading multiple Quality Management System programs within pharmaceutical, biotechnology, or medical device manufacturing environments.
• Experience with FDA, Health Canada, or other global regulatory authority inspections and responses.
• Proficiency with electronic Quality Management Systems (eQMS) such as TrackWise and analytics tools including Power BI, Tableau, Smartsheet, or advanced Excel reporting.
• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Six Sigma Black Belt, RAC, or comparable professional certification.

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 salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on 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

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.