Develop and execute a roadmap for IT systems (ERP, MES, QM, PM, LIMS) that supports manufacturing scalability, quality, and innovation
Optimize MSC related subsystems to enhance traceability, quality control, and supply chain visibility in medical device production; serve as Operations Business Process Owner on major implementations (e.g., S4 HANA)
Collaborate with global manufacturing, quality, supply chain, and IT teams to align system capabilities with functional needs and translate business requirements into technical specifications
Drive user adoption through training, documentation, change management strategies and establish a global network of SMEs
Ensure systems adhere to industry regulations (ISO, FDA, GDPR) and conduct audits and risk assessments to mitigate disruptions
Manage vendor and stakeholder partnerships, support Procurement in negotiations, resolve issues, and report strategic insights and ROI to executive leadership
Requirements
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