Vantive · 3 months ago
Consultant, IT QA RA Apps
Deerfield, Illinois
Full-time
Hybrid
Senior Level
$120K/yr - $150K/yr
7+ years expVantive is a vital organ therapy company focused on enhancing the dialysis experience through innovative digital solutions and advanced services. They are seeking a seasoned Technical Lead to oversee the IT system for TrackWise and adjacent Quality/Regulatory applications, ensuring they meet business requirements and remain validated throughout their lifecycle.
Health CareMedicalTherapeuticsWellness
Responsibilities
Serve as IT system owner for TrackWise, 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
Design, configure, and extend TrackWise 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, CloudWatch)
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
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
Qualification
Required
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 TrackWise 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 (PowerShell)
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 technical leadership; ability to mentor and set engineering standards
Preferred
TrackWise upgrade/migration experience (major version changes, remediation planning, vendor coordination)
Hands-on with event-driven architectures, message queues, or integration platforms (e.g., MuleSoft, Boomi)
Exposure to other QA/RA systems (e.g., Veeva QMS/RA, Labeling, PLM) and data exchange patterns
Experience with ServiceNow/ITSM, Agile methods (Scrum/Kanban), and regulated SDLC toolchains
Security-by-design mindset (identity/role design, audit trails, segregation of duties)
Benefits
Medical, dental and vision coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Aon Pooled Employer Plan (“Aon PEP”)
Vantive’s 401(k) retirement savings plan
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
The Employee Discount Program
The Employee Assistance Program (EAP)
Childcare benefits
Company
Vantive
Vantive US Healthcare LLC specializes in kidney care and organ support therapies with digital solutions.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-08-13Acquired
Recent News
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