**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.