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
Functional Ownership & Configuration
Testing & Release Management
Stakeholder Engagement
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
Work Authorization Requirements
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