Associate Director, ERP Functional & Solutions Architect

Kyowa Kirin is a fast‑growing global specialty pharmaceutical company that applies state‑of‑the‑art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan‑based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization.

In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

The Associate Director, ERP Functional & Solution Architect, ICT role will be responsible for overseeing MS D365 Enterprise Resource Planning (ERP) within the organization. Crucial role in implementing ERP specific business process improvements and enhancements within the organization and ensuring the system's optimal performance and functionality. Perform the planning, design, configuration, customization, and implementation of MS D365/ERP modules and functionalities, ensuring seamless integration with existing systems, ensuring compliance with industry standards, security protocols, and regulatory requirements.

The ERP Functional Architect, Associate Director, ICT role will also serve as a business process analyst aligned with enterprise (i.e., SCM, MFG, Quality) and Corporate Functions (i.e., Finance, HR, Legal, Compliance, Procurement) ensuring successful technical solution development and delivery.

• Solution Architecture & Design
  • Lead the functional design and architecture of the D365 F&O solution across key modules (Finance, Supply Chain, Manufacturing, Procurement, Inventory, Quality, etc.).
  • Translate complex business requirements into clear, scalable, and compliant functional solutions.
  • Emphasizes proactive, holistic leadership in solution architecture.
  • Focuses on aligning solutions with business goals, value streams, and enterprise architecture governance.
  • Define data flows, integrations, and system interactions between D365 and other enterprise systems & interfaces (e.g., LIMS, MES, 3PL Partners, External Finance Systems, and Cloud systems).
  • Ensure alignment with Microsoft’s Dynamics 365 roadmap and best practices.
• Implementation & Configuration
  • Perform and lead the setup, configuration, and deployment of D365 F&O modules.
  • End‑to‑end management of project/solution management by using tools like Azure Boards for planning and tracking work, Azure Repos for code versioning, and Azure Pipelines for automating build and deployment. Perform all activities from initial user stories and tasks to code, testing, and deployment through integrations with tools like Lifecycle Services (LCS).
  • Drive fit-gap analysis and functional documentation. Develop User/Functional Requirements, Functional/Technical Design, System/Business process architecture diagrams.
  • Collaborate with development/vendor/managed service teams to define functional specifications for enhancements, bug/fix, customizations, reports, and interfaces. Co‑develop or individually develop code/configurations required and coordinate internal development and user acceptance testing of the solution.
  • Participate in system validation activities, including IQ/OQ/PQ documentation for regulated environments.
• Governance & Compliance
  • Ensure the ERP system design complies with GAMP 5, SOX, and GxP regulatory requirements.
  • Develop and maintain master data governance, change management, and configuration control processes.
  • Support audits and inspections through proper documentation and traceability.
  • Develop current and future state roadmaps and architecture.
  • Assess and align system release plan with Microsoft Dynamics 365 roadmap.
• Stakeholder Collaboration
  • Partner with business process owners to define best practices, continuous improvement opportunities, and confirm desired solution to fix the support/bug‑fix items raised. Support communities of practice and collaborative development methodology.
  • Work independently to perform required fix within the D365 framework. Test and confirm the developed fix with business process owners.
  • Work closely with IT, OT,…