Quality Manager

Baxter • Round Lake, IL

1d • $112,000 - $154,000

About The Position

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. 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 day‑to-day 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 it's 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 there's 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.

Requirements

• Bachelor’s 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.
• 1–2 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, problem‑solving, and risk‑assessment skills
• Effective communication and collaboration skills across cross‑functional teams.
• Ability to manage multiple priorities and lead initiatives in a fast‑paced manufacturing environment.

Responsibilities

• 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 risk‑based 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 subject‑matter expert.
• Collaborate cross‑functionally 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees