Validata Functional SME Model N Flex Job at JUARA IT SOLUTIONS, California

b0t0RVFmdWN3TlJGdk9yaTQ3d05JTW9STkE9PQ==
  • JUARA IT SOLUTIONS
  • California

Job Description

Job Title: Validata Functional SME – Model N Flex

Location: Onsite – California, USA

Work Hours: 9 AM – 6 PM PST (Must support PST business hours)

Role Overview

We are seeking an experienced Validata Functional Subject Matter Expert (SME) with strong hands-on Model N Flex experience to support validation strategy, compliance workflows, test lifecycle management, and execution processes within a regulated life sciences environment.

This position is functionally focused (80% Functional / 20% Technical) and requires extensive experience in validation automation, business rules definition, traceability, and UAT coordination within the Model N Validata module.

The ideal candidate will engage directly with business stakeholders, compliance organizations, QA teams, and release managers to ensure validated, audit-ready delivery of Model N changes aligned with GxP and life sciences regulatory requirements.

Responsibilities

Validation & Compliance Leadership

  • Lead validation cycles for the Model N Validata module across enhancements, releases, and upgrades.
  • Define and maintain Validation Plan, Traceability Matrix, Test Scripts, and Acceptance Criteria.
  • Ensure alignment to regulatory frameworks: GxP, SOX, CFR Part 11, audit evidence, and documentation expectations.
  • Drive end-to-end compliance processes including validation automation, exception handling, and deviation management.

Functional Ownership & Configuration

  • Support Model N Flex configuration assessments including workflow mapping, business rules, orchestration logic, and regression impacts.
  • Collaborate with solution architects and business analysts to translate requirements into reusable validation scenarios and scripts.
  • Ensure alignment of configuration changes with compliance and audit readiness requirements.

Testing & Release Management

  • Facilitate UAT, validation execution cycles, defect triage, prioritization, and sign-off.
  • Coordinate with QA, PMO, Business, and Release Management teams to ensure controlled deployments aligned with validation procedures.
  • Ensure continuous improvement and optimization of Validata automation frameworks.

Stakeholder Engagement

  • Serve as onsite liaison with business owners, compliance leads, offshore development teams, and third-party partners.
  • Participate in steering committees, validation checkpoints, and readiness meetings.
  • Provide functional guidance, domain subject matter expertise, and risk-based validation recommendations.

Must-Have Qualifications:

Model N Validata Expertise

Deep hands-on experience with the Validata module including compliance workflows, automation, and reporting

Flex Platform Understanding

Working knowledge of Model N Flex workflows, rules, test orchestration, and configuration lifecycle

Functional SME Capability

Leading workshops, requirement discussions, validation cycles, UAT, and sign-off processes

Regulatory/Compliance

Experience in validated systems under GxP, SOX, CFR Part 11 environments

Stakeholder Experience

Proven onsite role interacting with business, compliance, QA, and release teams

Experience Range

10–12 years total IT experience, 5–7+ years Model N Flex, functionally dominant (80/20 split)

Nice-to-Have Qualifications:

Upgrade Experience

Experience supporting Model N Flex upgrades, regression cycles, and automation enhancement

Cross-Module Exposure

Model N Commercial and/or Medicaid / Regulatory module experience

Automation Tools

Experience optimizing automated test execution tools/frameworks

Life Sciences Domain

Understanding of revenue management, pricing governance, compliance expectations

Soft Skills & Competencies

  • Ability to simplify compliance language for business and technical teams
  • Strong analytical, risk-based thinking aligned to audit principles
  • Excellent communication, documentation, and presentation capability
  • Ability to influence stakeholders and manage validation governance

Work Authorization Requirements

  • Must be able to work onsite in the United States.
  • Applicants requiring sponsorship are not eligible at this time.

Job Tags

Remote job, Flexible hours,

Similar Jobs

FedEx Services

Package Handler - Part Time (Warehouse like) Job at FedEx Services

IMMEDIATE OPENINGS! Come for a job and stay for a career! Federal Express Corporation (FEC) is part of the rapidly growing warehouse and transportation sector that helps keep America, and our economy, moving. Be part of a winning team and workplace community that cares...

300 Second Avenue

Patient Sitter - Per Diem Night Job at 300 Second Avenue

 ...Job Title: Patient Sitter Location: Monmouth Medical Center Department Name: Nursing Float Pool Req #: 0000221682 Status: Hourly Shift: Night Pay Range: $16.19 - $18.17 per hour Pay Transparency: The above reflects the anticipated hourly wage range... 

Team Architects

Executive Assistant to CEO/VP Job at Team Architects

 ...Role: Executive Assistant to CEO Are you a proactive, detail-oriented professional who loves keeping high-level leaders organized and operations running smoothly? Horizon Trust Company is looking for a confident, resourceful Executive Assistant to support our Founder... 

Gilead Sciences

Associate Director, US Medical Affairs, Patient Access and Quality of Care (PAQ) - Portfolio Strategy Job at Gilead Sciences

 ...Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader...  ...of our day and improving the lives of patients for generations to come. We have an...  ...within US Medical Affairs for an Associate Director, Portfolio Strategy in our Patient... 

State of Ohio Jobs

2026 Summer College Intern - Communications and Outreach Job at State of Ohio Jobs

 ...Ohio Environmental Protection Agency wants you to be our newest intern on the Communications and Outreach team, working at our Central...  ...media productions (e.g., PowerPoint, still art and photos, animation projects, etc.). Sort and file resource materials (e.g., art...