QC Manager

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.

As the QC Manager, you will lead and organize the operations of the Microbiology and Chemistry Laboratories. You will work closely with Manufacturing, Supply Chain, Quality, Regulatory, and R&D teams to ensure laboratory testing activities are executed in compliance with FDA regulations, USP standards, company policies, and current Good Manufacturing Practices (cGMPs). This role is responsible for the development and implementation of laboratory policies, systems, procedures, specifications, and testing programs for Raw Materials, In-Process Materials, Finished Products, Stability Programs, and Method Transfers. You will also oversee laboratory validation activities, quality monitoring programs, and change control processes to support business priorities, quality objectives, and operational excellence.

Laboratory Leadership & Operations Direct and manage all Microbiology and Chemistry Laboratory operations. Coordinate laboratory activities with Manufacturing and Supply Chain teams. Lead, supervise, train, and develop exempt and non-exempt laboratory personnel. Ensure laboratory services are delivered efficiently, cost-effectively, and in compliance with applicable regulations and standards. Perform weekly, monthly, and annual reporting as required by site leadership and company procedures. Quality & Compliance Ensure compliance with all applicable FDA, USP, OSHA, EPA, cGMP, corporate, federal, and state requirements. Establish, implement, and maintain laboratory standard operating procedures and policies. Conduct and approve laboratory investigations, including root cause analysis activities. Conduct trend analysis, including Annual Product Review data evaluations. Ensure all laboratory changes are appropriately managed through the change control system. Maintain accountability for the Product Stability Program. Validation & Method Transfer Manage the laboratory validation program, including equipment, processes, test methods, software, and related systems. Lead and support method transfer activities where applicable. Participate in process validation and revalidation programs. Oversee testing and analysis of validation samples. Support continuous improvement initiatives through laboratory automation and testing method enhancements. Training & Performance Management Ensure laboratory analysts are properly trained and qualified to perform testing activities. Verify adherence to Good Laboratory Practices, company standards, and regulatory requirements. Routinely audit analyst performance, testing accuracy, and documentation practices to assess training effectiveness and compliance. Budget & Supplier Management Develop and manage departmental operating and capital budgets. Maintain laboratory technologies, software, and equipment in an updated state. Prepare and submit capital expenditure requests as needed. Ensure all laboratory service contracts are maintained and current. Evaluate and manage laboratory maintenance service suppliers.

Education & Experience Bachelor's degree in Chemistry, Microbiology, or a related scientific discipline. Minimum of 8 years of experience in Quality Systems within a regulated