Senior Director Operations - Quality Solutions

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our 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 sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

Your Role at Vantive:

The Senior Director - Quality Solutions for Kidney Care segment is accountable for implementing the mid-long term strategy, leading and directing all of the quality resources to support the new product development projects, commercialized products and to maintain and improve the compliance profile of the manufacturing facilities. This role is responsible for multi-plant management, within the scope of the role. The geographical responsibilities will evolve over time.

Your Team:

You will be part of a newly formed, growing team who supports Vantive’s mission to save and sustain lives through our talent. 

Additional Responsibilities:

• Cascade the Corporate Quality Goals at Entity level

• Support the Global and Regional leaders to accomplish the business strategies

• Integrate new businesses/acquisitions into the Vantive Quality System

• Responsible for sponsoring, planning and conducting special projects

• Communicate key measures, metrics and data, escalating potential product quality or safety issues, recommending risk mitigations/corrective action plans, and provide Quality input into all Sub-Business Strategies and Planning

• Ensure Quality Processes and Systems are developed and maintained that meet both customer and regulatory requirements; driving towards consistency with Corporate processes and standards, and ensuring that all relevant facilities and plant operations manage and maintain their Quality systems and organizations, monitor and meet key metrics and indicators, and look for ways to continuously improve compliance, cost and talent

• Supports all of the currently marketed products sold/produced by the Sub-Business; actively monitoring customer complaints, identifying potential quality or safety issues, assessing the potential risk, recommending mitigation strategies/actions, and effecting any field corrections, product removals, and corrective/preventative actions

• Partner with the development teams providing quality support and planning on all new product development projects; ensuring that all new products or product changes address customer needs and maintain or improve upon the quality of existing or competing products

• Act as the chief spokesperson and lead negotiator in planning and implementing all interactions with the relevant Regulatory Authorities and Agencies in order to maintain, resolve or improve European compliance standing

• Partner with Manufacturing to drive operational efficiencies, drive technical change and automation, resolution of productivity or quality issues, and on product transfers, closing existing facilities, and opening new facilities

• Lead and direct all of the relevant Quality organizations; setting, managing and communicating priorities based on the Business needs and strategies

• Responsible for conducting special projects on demand to drive Quality and Compliance

• improvement in alignment with Corporate and Patient Safety/GBU Product strategy

Required Skills:

• A Bachelor's Degree in the sciences or engineering disciplines, or a related discipline

• 15 ore more years of experience in Quality and/or manufacturing operations

• Technical experience in drug, biologics, and/or the medical devices industry (or a related industry)

• Strong leadership experience with managing teams of direct reports, preferably within a global quality and/or manufacturing operations environment

• Ability to travel globally at lease 25%

Additional Preferred Skills:

• A Master's Degree or above

• Strong leadership and management skills to support various company programs

• Expert in regulations related to cGMP and ISO

• Strong experience within compliance/regulatory issues

• Passion for continuous improvement through Quality tools and metrics

• Professional Project Management certification and/or experience

• Experience with managing Supplier Quality Processes and any related audit experience

• Operational experience in Change Control processes, complaint handling, CAPA processes, Internal auditing, Product Quality reviews, and/or validation

• Ability  to  work  cross-culturally,  and  to  develop  strong  relationships  with  senior regulatory agencies

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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.

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