Consultant, IT QA RA Apps

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.

We are seeking a seasoned Technical Lead to serve as the IT system owner and principal technical authority for Track Wise (Sparta Systems/Honeywell) and adjacent Quality/Regulatory applications. The role is responsible for ensuring Quality and Regulatory global applications meet business requirements and remain in a validated state throughout their lifecycle

This is a high-visibility, hands‑on leadership role responsible for the stability, configuration, integration, and lifecycle management of the enterprise QMS platform at Vantive.

The ideal candidate brings deep Track Wise configuration experience coupled with modern full‑stack engineering skills to drive reliability, scalability, and compliant change.

Product & System Ownership

• Serve as IT system owner for Track Wise, accountable for end‑to‑end technical health, roadmap, and lifecycle. Own incident/problem/change processes (ITIL) and SLAs; lead major incident triage and root‑cause analysis.

• Coordinate with vendor (Sparta Systems/Honeywell) for patches, upgrades, and support cases; manage risk and release notes impact assessments.

Configuration & Platform Engineering

• Design, configure, and extend Track Wise workflows, forms, business rules, records, and security/roles.

• Engineer robust integrations with ERP/MES/PLM/Labeling and other QA/RA systems (e.g., complaints, CAPA, audits) using Java/.NET and SQL Server; leverage scripting/automation where applicable.

• Leverage AWS for hosting patterns, automation, and resiliency (e.g., EC2, S3, RDS/SQL Server on AWS, IAM, Cloud Watch).

Validation, Compliance & Audit Readiness

• Operate within GxP and 21 CFR Part 11 requirements: lead Computer System Validation (CSV) deliverables.

• Maintain validation plans, IQ/OQ/PQ scripts, traceability matrices, risk assessments, and change controls.

• Support internal/external audits; ensure procedures, SOPs, and records are current and inspection ready.

Stakeholder Management & Leadership

• Engage business SMEs across Quality and Regulatory to capture requirements and translate to scalable technical solutions.

• Communicate status, risks, and decisions effectively to leadership; influence cross‑functional priorities.

• Bachelor's degree in computer science, Information Systems, Engineering, or related field;
  Master's a plus.

• 7‑10+ years of total IT experience with increasing responsibility in enterprise applications and integrations.

• Demonstrated success leading technical delivery in highly regulated industries (medical device, pharma, biotech).

• 3‑5+ years of hands‑on Track Wise configuration and administration (workflows, forms, rules, security, records, reporting).

• 2‑3+ years of modern full‑stack engineering with one or more:
  Java or .NET; strong SQL (Microsoft SQL Server); scripting (Power Shell).

• Experience with Docker containers and AWS services for hosting, automation, monitoring, and resilience.

• Proven delivery in validated (GxP) environments with 21 CFR Part 11 controls: strong change control and SDLC discipline.

• Solid understanding of performance engineering, observability, and incident/problem management (ITIL).

• Excellent communication, stakeholder management, and…