IT Systems Business Process Leader

Vor 4 Tagen

DEU Bad Homburg Global Headquarters, Deutschland Fresenius Medical Care Vollzeit

This role will lead the alignment of IT strategies with Operation's business goals, focusing on core systems such as Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Quality Management (QM), Computer Aided Quality (CAQ) ,Plant Maintenance (PM), Product Lifecycle Maintenance (PLM), and Laboratory Information Management Systems (LIMS), and who will bridge technical expertise with cross-functional collaboration to enhance efficiency, ensure compliance, and foster a culture of continuous improvement.

Your assignment:

1. Strategic System Vision:

  • Develop and execute a roadmap for IT systems (ERP, MES, QM, PM, LIMS) that supports manufacturing scalability, quality, and innovation.
  • Identify gaps in current systems and collaborate with ITS to propose solutions that streamline workflows, reduce costs, and improve data-driven decision-making.

2. System Implementation & Optimization:

  • As the Operations Business Process Owner, optimize MSC related subsystems to enhance traceability, quality control, and supply chain visibility in medical device production.
  • Serve as the designated Operations Business Process Owner (BPO) on major system implementations such as S4 HANA
  • Demonstrated ability to optimize global standards with local needs
  • Partner with MTI Engineers to pilot emerging technologies (IoT, AI, digital twins) to improve manufacturing efficiency and compliance reporting.

3. Cross-Functional Alignment:

  • Collaborate with global manufacturing, quality, supply chain (execution and planning), and IT teams to align system capabilities with functional needs.
  • Responsible for definition of business requirements and sign off that requirements have translated into technical specifications for system customizations and integrations.

4. Change Management & Adoption:

  • Drive user adoption through training, documentation, and change management strategies to ensure successful system rollouts.
  • Establish a global network of SMEs with focus on different processes, production and product types

5. Compliance & Risk Management:

  • Ensure systems adhere to industry regulations (e.g., ISO, FDA, GDPR) and internal quality standards.
  • Conduct audits and risk assessments to mitigate potential disruptions to manufacturing processes.

6. Vendor & Stakeholder Partnerships:

  • Manage relationships with key vendors and service providers to take expert role together with Procurement to negotiate contracts, resolve issues, and drive innovation.
  • Report progress to executive leadership and stakeholders, including ROI analysis and strategic insights.

Your profile:

  • Bachelor's degree in Information Technology, Engineering, Computer Science, or a related field (Master's degree preferred)
  • Minimum 8 years experience in manufacturing related IT, with a proven track record leading system implementations (ERP, MES, QM, etc.).
  • Experience in medical device manufacturing IT or other regulated industry
  • Proven track record leading cross-regional IT infrastructure projects (e.g., plant setups in EMEA, APAC)
  • Mastery of ERP (SAP, Oracle), MES (Rockwell, Siemens), and QMS/LIMS platforms tailored for medical devices manufacturing sites
  • Familiarity with electronic quality management systems (eQMS), serialization, and compliance tracking tools
  • Ability to navigate cultural nuances, time zones, and regional compliance complexities
  • Ability to influence stakeholders, manage cross-functional projects, and drive organizational change
  • Exceptional written/verbal communication skills in English. Ability to translate technical details into business outcomes.

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