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. 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 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. 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. What we offer from Day One 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 What you'll be doing 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. What you'll bring 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 or a related field, with prior experience in pharmaceutical or medical device environment preferred. Minimum of 1 year 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 penicillin, 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. Ability to work with minimal supervision. Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. 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 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 upon location, skills and expertise, experience, and other relevant factors. 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. Other Duties as Assigned Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required. 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. 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. Know Your Rights: Workplace Discrimination is Illegal #J-18808-Ljbffr Baxter