Validata Functional SME Model N Flex California

Position: Validata Functional SME Model N Flex at JUARA IT SOLUTIONS California
Location: California

Validata Functional SME Model N Flex job at JUARA IT SOLUTIONS. California.

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.

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