D365 System Site Owner, Pharmaceutical Manufacturing

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington Indiana US and Halle/Westfalen Germany we offer a wide range of delivery systems including pre-filled syringes liquid/lyophilized vials diluents for reconstitution powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules cytotoxics highly potent compounds diluents for reconstitution and vaccines which are all directly injected into patients worldwide. As such there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing we offer many support services including formulation and development lyophilization optimization global regulatory support and secondary packaging. Our teams are driven to help clients scale innovate and bring life-changing medicines to patients worldwide.

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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:

• Bachelors 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 youll be eligible for1:

• 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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