Job Description

Role: Validation Specialist, D365 (Supply Chain Modules)

REMOTE

Duration: 3+ Months (extendable up to 12 Months)

Overview:

Our client is seeking a D365 Validation Specialist to support the validation of Microsoft Dynamics 365 (D365) Supply Chain modules in a GxP-regulated environment. This role is key to enabling a successful go-live targeted for September 8th, and requires an expert who can lead validation strategy and execution from the ground up using CSA (Computer Software Assurance) principles.

This engagement includes a unique supply chain model where all manufacturing is outsourced across four contract manufacturers (CMOs). Materials are purchased directly by the CMOs, and Avidity’s internal QA team performs batch disposition reviews and approvals before materials move between sites. The validation strategy must align with this distributed and regulated manufacturing process.

Key Responsibilities:

• Perform the end-to-end validation of Microsoft Dynamics 365 modules in scope:
• Cost Management
• Fixed Assets
• Inventory Management
• Product Information Management
• Production Control
• Warehouse Management
• (Potentially) Project Management & Accounting

• Develop and execute a CSA-aligned validation strategy tailored to the client's outsourced manufacturing model
• Author and manage validation deliverables: risk assessments, validation plans, test scripts, traceability matrices, and final reports
• Work cross-functionally with QA, IT, and business users to ensure GxP requirements are met
• Collaborate with the implementation consulting team to validate system configurations and customizations
• Translate requirements stored in Azure DevOps into formal validation documentation
• Assist in transforming validation materials for use in systems of record (e.g., Veeva)
• Provide guidance on validation-related SOPs and help improve existing documentation processes
• Serve as the primary validation lead in a no-playbook environment (strategy development required)

Required Qualifications:

• 5+ years of experience in validation of GxP systems within the life sciences industry (pharma, biotech, or med device)
• Direct experience validating Microsoft Dynamics 365 (or similar ERP)
• Strong working knowledge of CSV and CSA methodologies and relevant regulatory frameworks (FDA, EMA, 21 CFR Part 11, GAMP 5)
• Experience supporting supply chain operations in outsourced manufacturing environments
• Excellent technical writing skills with ability to work independently in a manual documentation environment
• Strong communication skills and ability to collaborate with QA, IT, and external implementation partners
• Comfortable working in fast-paced, timeline-driven projects without pre-existing templates or tools

Preferred Qualifications

• Familiarity with Azure DevOps for managing requirements and system configurations
• Experience with validation strategy design from the ground up
• Exposure to Veeva or similar systems for change control or document management
• Knowledge of biotech manufacturing processes, batch disposition, and multi-CMO coordination

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