Senior Manager, Quality Management System - (Facilities, Production, Process & Test Controls),

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.

This is where your creativity addresses challenges

You 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 drive 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.

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.

• Responsible 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 segments
• Provides 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 documents
• Measures and reports quality system deployment effectiveness and drives continuous improvement initiatives based upon stakeholder feedback
• Guides 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 outcomes
  

• Bachelor's degree in science or engineering; advanced degree helpful
• 7 years’ experience working in Quality, Manufacturing, Engineering or related field
• 3 years’ experience working in manufacturing plant, laboratory and/or technical service
• Knowledge and understanding of international regulations and standards
• Experience with regulatory agencies and/or notified bodies, including explaining and defending process and policies
• Strong leadership skills, capable of managing multiple priorities
• Strong interpersonal skills, able to effectively communicate, influence and negotiate a highly matrixed organization
• Strong project management and technical writing skills
• Must be able to travel, if needed

Baxter 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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