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Consultant, IT QA RA Apps
Consultant, IT QA RA AppsVantive Health LLC • Deerfield, IL, US
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Consultant, IT QA RA Apps

Consultant, IT QA RA Apps

Vantive Health LLC • Deerfield, IL, US
19 days ago
Job type
  • Full-time
Job description

Your Role

We are seeking a seasoned Technical Lead to serve as the IT system owner and principal technical authority for TrackWise (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 TrackWise configuration experience coupled with modern full-stack engineering skills to drive reliability, scalability, and compliant change.

What You'll Be Doing

Product & System Ownership

  • 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.

Configuration & Platform Engineering

  • 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).
  • 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.
  • What You'll Bring

  • 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.
  • Technical Stack

  • TrackWise (Sparta Systems / Honeywell).
  • Java or .NET (C#), REST / SOAP services, JSON / XML.
  • Microsoft SQL Server (T-SQL), performance tuning, stored procedures.
  • AWS (e.g., EC2, S3, IAM, CloudWatch) and on-prem connectivity patterns.
  • Docker; scripting / automation with PowerShell; optional Node.js or front-end technologies for UI extensions.
  • Source control and CI / CD (e.g., Git, Azure DevOps / GitHub Actions); environment promotion under CSV constraints.
  • Preferred Skills

  • 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).
  • Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

    We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $120,000 to $150,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position is also eligible for a discretionary bonus. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

    US Benefits at Vantive

    This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), Vantive's 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

    We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Vantive's US Benefits, please speak with your recruiter or visit our Benefits site : Benefits | Vantive

    Equal Employment Opportunity

    Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status or any other legally protected characteristic.

    Know Your Rights : Workplace Discrimination is Illegal

    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

    Recruitment Fraud Notice

    Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and / or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice

    510 Lake Cook Road Deerfield, IL 60015 United States of America

    J-18808-Ljbffr

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