Senior Specialist, IT - Quality & Regulatory

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.

Your role at Vantive

Nothing changes if nothing changes, which is why Vantive is transforming our global IT function—into one that will strengthen partnerships and enable smarter, more efficient and connected business processes. In the dynamic healthcare industry, we need to be ready to face new challenges and opportunities. As we learn, we must be agile and innovative to reveal new ways of working. Technology and our digital capability will help create a more efficient and innovative ecosystem to enable our employees, customers and products to drive better outcomes for patients worldwide.  

We are at the critical intersection where robust IT infrastructure and networking support meets the physicians, nurses and care givers who save and sustain lives. Together, we can build upon Vantive’s rich heritage to advance the next generation of transformative healthcare innovations. Together, we can change how IT meets healthcare. Together, we are Vantive.  
This is where technology fuels purpose-driven work. Where your purpose accelerates our mission.

As a Sr Spec, IT – Quality & Regulatory, you will analyze business processes for a quality management system, from an IT perspective. This is an IT position, but heavily focused on customer interaction.  Your primary focus will be on identify, evaluate, develop and/or redesign systems and procedures to meet user requirements. You will also create detailed written user and functional requirements for developers and validation team and will assist in the development of training materials, as needed.

Your team

The Global Information Technology Centers are focused on being a stronger business partner, aligned to deliver on the technology needs and maintaining global support and shared expertise to advance digital capabilities across the enterprise. Our IT function is made up of employees with varied backgrounds and knowledge. This diversity of skills and expertise allows us to bring creative and innovative solutions.

What you'll be doing

• Gather, analyze, and document business requirements, workflows, and process improvements, translate business needs into functional and technical specifications.

• Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications.

• Provide primary system ownership of Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (CSV) requirements.

• Implement solutions that align with business needs and regulatory requirements.

• Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records.

• Lead Computer System Validation (CSV), ensure applications meet FDA, ISO 13485, and global regulatory standards.

• Develop and execute test scripts, UAT scenarios, and validation plans for new implementations and system changes.

• Manage issue triage, root cause analysis, and resolution for system defects.

• Support global Quality and Regulatory IT projects, including new system implementations and digital transformation initiatives.

What you'll bring

• Bachelor’s degree in Computer Science, Information Systems, or a related field.

• 3+ years of experience in IT business analysis, system ownership, or validation in Life Sciences industry.

• Ability to develop and execute test scripts, validation plans, and system documentation.

• Strong technical foundation with hands-on experience in enterprise application support, configuration, and deployment.

• Basic understanding of Java, .NET, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries.

• Experience in a regulated healthcare, pharma, or life sciences environment with understanding of CSV (Computer System Validation) and GxP requirements.

• Strong written and verbal communication skills, including ability to present to global teams.

• Strong problem solving, analytical and documentation skills.

• Microsoft Word, Excel, PowerPoint, and Visio skills 

Reasonable Accommodation

Vantive 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. Form Link

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