Manager, Quality

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.

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 penicillin 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.

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

• Interacts with manufacturing and supervision on a daily basis to address quality process or batch related concerns.
• Performs process compliance audits of all manufacturing areas to ensure quality of product/process is achieved.
• Develops, assigns, and implements systems, procedures and policies to assure compliance with cGMP's and FDA regulations and company policies and procedures. Assess all plant systems, operations, products, processes, procedures, and documentation for adequacy and effectiveness to ensure Quality and Regulatory Compliance related to CA/PA.
• Applies problem solving logically and in an organized manner. Must have experience with Root Cause Analysis tools and the ability to apply tools to plant scenarios.
• Manages a team of individuals to drive correction, prevention, and improvement throughout the plant. Is responsible for results in terms of timeliness and conformance to regulations and Baxter quality policies.
• Manages documentation and data requests from Pharma clients, division, and product development and support functions related to QM Manufacturing Quality Assurance and batch release.
• Maintains appropriate quality metrics for trend analysis and Management Review.
• Must have good working knowledge of plant systems, processes, procedures, documentation, and products.
• Plays an active role on quality management teams within the organization.
• Manage activities of self and Technicians in achieving defined safety, quality, and production goals.
• Manages the control and storage of released printed materials and retention samples.
• Should be able to communicate at all Plant and Divisional levels.
• Assist in external and internal audits by collecting relevant information such as SOP’s and routers.
• Drives efforts to identify and implement process efficiencies in order to achieve established release goals.
• Seeks new ways to improve and streamline current business and system processes.
• Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements.
• Performs process compliance audits for areas of responsibility.
• Review and approve batch documentation.
• Review and approve systems documentation.

• Must not be allergic to Penicillin or Cephalosporin drugs.
• Bachelor’s degree in Science, Engineering, or a related discipline required.
• Minimum of 3 years of experience in Quality…