Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

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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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.

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