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
As the Sr Specialist, IT RA Global Apps, you will:
Own and manage Regulatory applications, ensuring they are designed, operated, and maintained per business requirements.
Serve as the functional business analyst, gathering and analyzing business needs, defining requirements, and architecting solutions.
Lead system validation, testing execution, and change management in a regulated environment.
Oversee system maintenance, upgrades, defect tracking, and issue resolution in collaboration with IT and business teams.
Act as the primary liaison between IT, business process owners, and external vendors.
What you'll be doing
1. System Ownership & Governance
Serve as the primary system owner for 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.
Ensure systems remain in a validated state throughout their lifecycle.
2. Functional Business Analysis & Solution Design
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.
Ensure solutions are scalable, compliant, and aligned with Vantive’s digital transformation strategy.
3. Validation, Testing & Compliance
Lead Computer System Validation (CSV) efforts, ensuring 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 risk assessments, audits, and regulatory inspections related to system validation and compliance.
4. System Maintenance, Enhancements & Issue Resolution
Oversee system upgrades, patches, and maintenance, recommending enhancements as needed.
Manage issue triage, root cause analysis, and resolution for system defects.
Work closely with business process owners to ensure applications align with operational needs.
Coordinate with vendors and internal teams for system support and enhancements.
5. Stakeholder Collaboration & Project Support
Act as a key liaison between IT, Quality, Regulatory, and business stakeholders.
Support global Quality and Regulatory IT projects, including new system implementations and digital transformation initiatives.
Provide end-user training and support, ensuring smooth adoption of system enhancements.
Assist with project management tasks, ensuring timely delivery of IT solutions.
6. Technical Skills & Experience
The ideal candidate should have a strong technical foundation with hands-on experience in enterprise application support, configuration, and deployment. Key technical competencies include:
Programming & Scripting: Basic understanding of Java, .NET, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries.
Cloud & Infrastructure: Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment.
Validation & Compliance: Experience working in a regulated life science environment with understanding of CSV (Computer System Validation) and GxP requirements, including writing and executing IQ/OQ/PQ scripts
Cloud Computing and Data Management: Familiarity with SaaS environments (e.g., Veeva Vault Platform, Salesforce-based systems), including workflows, lifecycles, and user permissions.
Regulatory Domain: Hands-on experience with platforms like Veeva Vault QMS, TrackWise Digital. Understanding of regulatory process and submissions, including submission registration and publishing, promotional materials, etc. regulatory authorities, global registration of products,
The candidate should be able to collaborate with developers, business analysts, and cloud teams, ensuring seamless deployment, maintenance, and optimization of critical Quality and Regulatory applications.
Open to applicants across the country, this is a remote position
What you'll bring
Educational and/or Experience:
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/Pharmaceutical/Medical Device industry.
Hands-on experience with Veeva, TrackWise, or other Regulatory/Quality applications.
Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance.
Ability to develop and execute test scripts, validation plans, and system documentation.
Technical knowledge of SQL, system integrations, and application configuration.
Spanish and English speaking and written communication skills are mandatory.
Analytical Thinking: Ability to analyze complex business requirements, map them to system capabilities, and identify gaps or risks. Problem-solving skills to troubleshoot system issues while maintaining regulatory compliance.
Communication and Collaboration: Strong verbal and written communication to liaise between IT, quality assurance (QA), regulatory affairs, and business stakeholders. Ability to translate technical concepts into actionable insights for non-technical teams (e.g., explaining validation requirements to QA).
Attention to Detail: Precision in documenting system changes, validation protocols, and SOPs to withstand regulatory audits.
Preferred Qualifications
Experience with Veeva, Salesforce, AWS, Azure, or cloud-based environments.
Basic project management experience (Agile, Waterfall, or hybrid methodologies).
Strong problem-solving and analytical skills to address complex system issues.
Excellent communication and stakeholder management skills.
Project Management: Basic project management skills to coordinate system upgrades (e.g., Veeva’s 3 annual releases), implementations, or process improvements. Familiarity with methodologies like Agile or Waterfall, often used in IT projects.
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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