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 including Electromechanical, Disposables, Containers, and Software products. Includes all lifecycle phases from late-stage feasibility through development, sustaining, and discontinuation.
• Fulfill the role of subject matter expert for Product Lifecycle Management during internal and external inspections. Responsible for the success of quality and regulatory inspection preparedness, outcomes, and overall quality system compliance.
• Leads and directs element quality system implementation, integration, and harmonization for strategic acquisitions, system remediation, complex quality system scenarios, and projects requiring specialized quality system knowledge and experience.
• Work effectively and influence multiple functions (Quality, R&D, Operations, Commercial, Regulatory, Supply Chain, Medical, etc.) to ensure product lifecycle control expectations are met.
• Monitors, develops, and ensures compliance with company policies and procedures (e.g., compliance with FDA, BSI, MoH, ISO, MDR, MedDev, ANVISA, etc.)
• Develops strategies and processes for quality goals based on the business strategies and aligns with all business units and quality system elements.
• Establishes and implements necessary communication strategies for the improvement and awareness of quality improvements as needed to build a quality culture and maintain an ‘Always Inspection Ready’ mentality.

What you'll bring

• Bachelor’s degree in Science or Engineering. Master’s Degree preferred.
• Minimum of 7 years’ experience of working within a highly regulated environment (preferably healthcare – medical device/pharma) and have experience in communicating with government or statutory authorities.
• Minimum of 5 years’ experience supervising employees.
• At least 4 years of direct experience with Quality Management Systems and regulations. Previous manufacturing experience preferred.
• Minimum 5 years’ experience with external regulatory notified bodies and competent authorities (front room, SME, audit facilitator, back room, audit preparation).
• Certifications in Quality Management and on relevant standards preferred (ASQ Certification, ISO training etc.)
• The work environment is a significantly dynamic environment, where the need to adapt to change quickly and easily, show flexibility, adjust prioritization of tasks and workload for self and others, and time management skills are critical skills for success.
• A wide range of activities are undertaken from long term strategy development to short term crisis management. Capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy global, regional, and local objectives to effectively manage action plans that will resolve issues.

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 $120,000-$165,000 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. 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.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.

Recruitment Fraud Notice

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