at Baxter Healthcare Corporation in Deerfield, Illinois, United States
Job Description
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Your Role at Baxter
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 Sr. Manager, Quality PDLM, 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.
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.
Responsible for the strategic leadership of the Product Development and Lifecycle Management (PDLM) Element of the Quality System including creation, implementation, and continuous improvement for all global Baxter sites (design centers, plants, and service centers), strategic acquisitions, remediations, and special assignments.
Acts as the primary subject matter expert (SME) - Element Steward - for the product lifecycle management system while building and maintaining relationships with the global businesses including R&D, Supply Chain, Supplier Quality, Post-Market Surveillance, Worldwide Medical, Marketing, and Regulatory Affairs to ensure alignment on strategic initiatives.
What you'll be doing
Responsible for the strategic leadership of the Product Design Lifecycle Management element; including Global Quality Requirement and Process development, maintenance, training, and implementation of processes across the company to assure consistent, high-quality products and compliance with worldwide regulatory requirements.
Manage interface with global audit team to support audit plans, due diligence plans, and inspection readiness plans. Provides support for internal audits and external inspections; including interfacing directly or indirectly with the FDA, EMA, MHRA, ANVISA, MoH, TuV, BSI, etc.
Develops new and improved processes in collaboration with other QMS element Stewards and global leadership. Influences the decision-making process to ensure quality requirements are included when improvement initiatives take place.
Provide quality systems support for all products... For full info follow application link.
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.
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