D365 System Site Owner, Pharmaceutical Manufacturing

Simtra BioPharma Solutions•Bloomington, IN

4d•Onsite

About The Position

The Dynamics 365 (D365) System Owner provides strategic leadership and business ownership of the Microsoft Dynamics 365 platform within a pharmaceutical contract manufacturing (CDMO/CMO) environment. This role is responsible for driving the governance, optimization, and continuous improvement of D365 to support Supply Chain, Manufacturing, Inventory Management, Procurement, Planning, Warehousing, and related business operations. Partnering closely with cross-functional teams including Supply Chain, Manufacturing, Quality, Finance, Regulatory Affairs, Validation, and IT, the D365 System Owner ensures system capabilities align with business objectives, GMP and regulatory requirements, and organizational growth strategies while enhancing operational efficiency, data integrity, and overall business performance.

Requirements

Bachelor's degree in Supply Chain Management, Operations, Engineering, Information Systems, Business Administration, or related field.
5+ years of experience supporting ERP systems in a manufacturing environment.
3+ years of hands-on Microsoft Dynamics 365 Supply Chain Management experience.
Experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
Strong understanding of supply chain planning, inventory management, procurement, warehousing, and production processes.
Experience with system validation and change control processes.
Demonstrated project management and business process improvement experience.
Strong analytical, problem-solving, and communication skills.

Nice To Haves

Experience in pharmaceutical contract manufacturing (CMO/CDMO).
Knowledge of GMP, GxP, FDA, and regulatory requirements.
Experience with production orders, batch manufacturing, inventory traceability, serialization, and warehouse management.
Experience supporting D365 integrations with MES, LIMS, WMS, EDI, planning, or quality systems.
APICS/ASCM certification (CPIM, CSCP) preferred.
Lean Six Sigma certification preferred.
Experience leading ERP implementations or significant system transformations.

Responsibilities

Serve as the business owner and subject matter expert for Microsoft Dynamics 365 Supply Chain Management, ensuring alignment with business objectives and operational needs.
Establish and maintain ERP governance, business processes, system standards, and user adoption strategies.
Lead system roadmap planning, enhancement prioritization, and cross-functional ERP steering committee initiatives.
Partner with Supply Chain, Manufacturing, Production Planning, Procurement, and Warehouse teams to optimize end-to-end business processes.
Drive continuous improvement initiatives to enhance inventory accuracy, production efficiency, service levels, and operational performance.
Leverage D365 capabilities to streamline workflows, automate manual processes, and improve overall business throughput.
Ensure ERP processes support GMP requirements, data integrity standards, validation activities, and regulatory compliance within a pharmaceutical manufacturing environment.
Collaborate with Quality Assurance and Validation teams to support system changes, audit readiness, and compliance documentation.
Govern master data including item masters, bills of materials (BOMs), routings, vendors, customers, and inventory attributes to ensure data accuracy and integrity.
Develop and monitor key performance indicators (KPIs) related to data quality, supply chain performance, and process compliance.
Lead ERP-related projects, including system enhancements, integrations, upgrades, testing, validation, and change management activities.
Translate business requirements into scalable system solutions by partnering with IT teams, developers, and external vendors.
Develop and maintain operational reporting, dashboards, and analytics to support data-driven decision-making.
Analyze supply chain and manufacturing performance metrics to identify trends, risks, and opportunities for improvement.
Serve as the primary escalation point for D365 and business process issues, ensuring timely resolution and system reliability.
Create and maintain training materials, standard operating procedures (SOPs), and user documentation.
Drive user adoption through training, coaching, and continuous improvement initiatives.
Support business continuity planning, system readiness activities, and ongoing operational excellence efforts.