D365 System Site Owner, Pharmaceutical Manufacturing

Simtra US LLC; Bloomington (IN); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Plan with Match

Paid Holidays

Paid Time Off

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra US LLC is seeking a Dynamics 365 System Owner to lead governance, optimization, and continuous improvement of the D365 platform within a pharmaceutical CDMO/CMO environment. You will partner with cross-functional teams to ensure system alignment with GMP, regulatory requirements, and business goals while improving data integrity and operational performance.

The role covers governance, roadmapping, and collaboration with IT, Supply Chain, Quality, and Finance to optimize end-to-end

Qualifications

• Bachelor's degree in a related field (Engineering, IS, Supply Chain, etc.).
• 5+ years supporting ERP systems in manufacturing.
• 3+ years hands-on D365 SCM experience.
• Experience in regulated manufacturing (pharma/biotech/medical devices).
• Strong knowledge of supply chain processes and data integrity.

Responsibilities

• Own D365 Supply Chain Management for the business objectives and operations.
• Establish ERP governance, processes, standards, and user adoption strategies.
• Lead system roadmap planning and cross-functional ERP initiatives.
• Collaborate with Supply Chain, Manufacturing, Procurement, and Warehouse teams.
• Drive continuous improvement: inventory accuracy, efficiency, and service levels.
• Leverage D365 to streamline workflows and automate processes.
• Ensure GMP and regulatory compliance, validation activities, and data integrity.
• Collaborate with QA/Validation for changes and audits.

Skills

ERP systems

D365 SCM

Project management

Analytical thinking

Communication

Education

Bachelor's degree (related field)

Tools

Microsoft Dynamics 365

APICS CPIM/CSCP (preferred)

Job description

Why join Team Simtra?

Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

This role:

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.

The 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.

Required qualifications:

• 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.

Preferred qualifications:

• 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.

Physical / Safety Requirements:

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require sitting or standing for long hours of time

In return, you'll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
  • Vision Coverage
  • Accident
  • Critical Illness
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal and more
• Onsite Campus Amenities
  • Workout Facility
  • Cafeteria
  • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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