Quality Manager

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

Your Role at Baxter

This is where your creativity addresses challenges

The Quality Manager serves as the accountable quality leader for dedicated manufacturing operations at the Round Lake Drug Delivery site. This role is responsible for ensuring compliant execution of manufacturing activities through direct QA oversight robust quality system execution and effective people leadership.

The manager oversees daytoday quality performance within the cephalosporin area including batch disposition deviation and CAPA execution and strict adherence to contamination control and segregation requirements. The role partners closely with Manufacturing Engineering Microbiology Supply Chain and other stakeholders to ensure safe compliant and reliable product supply.

Your Team at Baxter

Within Quality every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether its building a new process from scratch or facing a never-before-seen production hurdle individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds we will always choose quality. Our patients come first always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable ethical and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when theres a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What youll be doing

• provide direct Quality Assurance oversight of cephalosporin manufacturing operations across assigned areas and shifts.
• Ensure strict adherence to cephalosporin segregation contamination control and cleaning validation requirements.
• Review and approve GMP documentation including batch records deviations investigations and change controls.
• Support batch disposition activities and ensure timely compliant release decisions.
• Identify assess and escalate quality and compliance risks impacting product quality or patient safety.
• Lead deviation NCR CAPA complaint and change control processes to ensure thorough timely and riskbased outcomes.
• Monitor and trend quality metrics to identify performance gaps and emerging risks.
• Maintain continuous inspection readiness and participate in regulatory inspections as a Quality subjectmatter expert.
• Collaborate crossfunctionally with Manufacturing Engineering Maintenance Facilities Planning and Microbiology.
• Provide QA support for equipment qualification process changes and technical improvement initiatives.
• Lead coach and develop a team of Quality professionals setting clear expectations for performance and compliance.
• Drive continuous improvement initiatives that enhance compliance reliability and operational efficiency.

What youll bring

• Bachelors degree in Science Engineering or a related discipline required.
• Minimum of 5 years of experience in Quality or a related field with prior experience in pharmaceutical or medical device environment required.
• 12 years of people leadership or supervisory experience required.
• Demonstrated knowledge of cGMP regulations (FDA EU PIC/S) and quality systems.
• Experience with batch record review deviations investigations and CAPA management.
• Strong understanding of contamination control and manufacturing compliance principles.
• Experience supporting cephalosporin sterile injectable or highly potent manufacturing operations.
• Strong analytical problemsolving and riskassessment skills
• Effective communication and collaboration skills across crossfunctional teams.
• Ability to manage multiple priorities and lead initiatives in a fastpaced manufacturing environment.

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 $112000 - $154000 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 on 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.

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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 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.

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