JUARA IT SOLUTIONS · 1 month ago
Validata Functional SME Model N Flex
California, California, United States
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expJUARA IT SOLUTIONS is seeking an experienced Validata Functional Subject Matter Expert (SME) with strong hands-on Model N Flex experience to support validation strategy and compliance workflows in a regulated life sciences environment. The role involves leading validation cycles, ensuring compliance with regulatory frameworks, and engaging with various stakeholders to deliver validated changes aligned with GxP requirements.
BlockchainCyber SecurityInformation TechnologySoftware Engineering
No H1B
Responsibilities
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
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
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
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
Qualification
Required
Deep hands-on experience with the Validata module including compliance workflows, automation, and reporting
Working knowledge of Model N Flex workflows, rules, test orchestration, and configuration lifecycle
Leading workshops, requirement discussions, validation cycles, UAT, and sign-off processes
Experience in validated systems under GxP, SOX, CFR Part 11 environments
Proven onsite role interacting with business, compliance, QA, and release teams
10–12 years total IT experience, 5–7+ years Model N Flex, functionally dominant (80/20 split)
Preferred
Experience supporting Model N Flex upgrades, regression cycles, and automation enhancement
Model N Commercial and/or Medicaid / Regulatory module experience
Experience optimizing automated test execution tools/frameworks
Understanding of revenue management, pricing governance, compliance expectations
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
Company
JUARA IT SOLUTIONS
JUARA IT SOLUTIONS offers managed IT, cloud, blockchain services, technology consulting, IT device rentals, and software development.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase