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,

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