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.
The Product Quality Manager will act as the manager of the product quality solutions & containers team. You will ensure global quality of the solutions & containers products.

KNOWLEDGE AND SKILLS:

• Knowledge of FDA (21 CFR Part 210, 211 & 820), ICH, and EMEA regulations (EU, GMP Part I & II) and ISO 13485 and 14971, MDR.
• Experience in leading project teams and Quality Initiatives (processes, systems, improvements) in an international environment.
• Strong communication and organizational skills.
• Compliance knowledge in the areas of pharmaceutical product and medical devices development, change control, CAPA.
• Ability to articulate customer needs and incorporate them into work.
• Ability to work with minimal supervision and to make decisions even if provided with limited information.
• Strong analytical and problem-solving skills, preferably utilizing DMAIC tools; Six Sigma Engineering.
• General understanding of applied Statistical Methodologies.

EDUCATION AND/OR EXPERIENCE:

• University degree in Pharmacy, Engineering, Chemistry, or Biochemistry.
• Minimum of five years’ experience in the pharmaceutical or medical device environment.

• Ensure Quality System processes are correctly implemented to meet requirements for new product development and lifecycle management for medical devices and drug products.
• Provide and lead the core teams to achieve Quality deliverables that are required to support regulatory submissions of new products to Notified Bodies, MoH, and the FDA.
• Provide technical and leadership support for the execution/implementation of the assigned tasks related to New Product Development (NPD), Sustaining Engineering (SPO), and Regulatory Compliance projects.
• Ensure sites and team audit readiness for internal and external audits.
• Lead and approve NCR/CAPA projects.
• Accountable for timely and accurate reporting of PQDR (Product Quality Data Reviews) data to ensure that post-production information is used as input for proactive improvement of products’ performances.
• Drive implementation of best practices in Product Development and lifecycle management processes, including Change Management and Risk Management.
• Provide guidance on maintenance of product Design History Files and other Management Files according to relevant Quality System and other Regulatory requirements for therapeutics and medical devices.
• Interface with Research & Development, Regulatory Affairs, Medical, Manufacturing, and other disciplines to represent QA in project teams, with the objective to assure that the project quality objectives are met.
• Drive and champion the awareness and implementation of Vantive Quality policy and objectives.
• Manage Product Quality resources and budget for the solutions and containers team, also responsible for the team’s development and training.