Senior Manager, Quality Management System

5 days ago

Deerfield, United States Disability Solutions Full time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. Your Role at BaxterThis is where your creativity addresses challengesYou are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Senior Manager, Quality Management System, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.This role is responsible for establishing policies and procedures that drives continuous improvement and regulatory compliance of Chapter 3 - Facilities, Production, Process & Test Controls within Baxter’s global Quality Management System. Chapter 3 includes facilities design and control, critical equipment and systems, validation, production controls, and laboratory processes used for product release and submissions.Your Team at BaxterWithin 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 you'll be doingResponsible for the lifecycle management of policies and procedures in the GxP Quality Management System (QMS) framework, including enforcing QMS governance and providing support with document authoring, approval and development of implementation strategies for the segmentsProvides direction and/or facilitates SME participation forums (Subject Matter Expert Councils/Communities of Practice/Governance) needed for the development and maintenance of compliant global QMS process documentsMeasures and reports quality system deployment effectiveness and drives continuous improvement initiatives based upon stakeholder feedbackGuides and supports global information technology (IT) system implementations (i.e.: eQMS)Frequently interacts with all levels of the organization to collaborate on key initiatives needed to drive desired QMS outcomesWhat you'll bringBachelor's degree in science or engineering; advanced degree helpful7 years’ experience working in Quality, Manufacturing, Engineering or related field3 years’ experience working in manufacturing plant, laboratory and/or technical serviceKnowledge and understanding of international regulations and standardsExperience with regulatory agencies and/or notified bodies, including explaining and defending process and policiesStrong leadership skills, capable of managing multiple prioritiesStrong interpersonal skills, able to effectively communicate, influence and negotiate a highly matrixed organizationStrong project management and technical writing skillsMust be able to travel, if neededBaxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.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 $128,000 - $176,000 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 on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and/or long-term incentive. 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.#LI-AR1Bachelor's Degree (16 years)Equal Employment OpportunityBaxter 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.EEO is the Law EEO is the law - Poster SupplementPay Transparency PolicyReasonable AccommodationsBaxter 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.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.SummaryLocation: Deerfield, Illinois; Round Lake, IllinoisType: Full time

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