Global Plant IT Leader: MES, GxP & Regulatory Tech

1720 embecta Medical II LLC; Milano; On-site; EUR 150,000 - 210,000; Full time

Job summary

embecta is a global medical device company seeking a Sr. Director, IT-R&D, Manufacturing, Quality, and Regulatory to lead global MES, SAP Manufacturing, GxP validation, and regulatory tech strategy across six plant sites.

The role partners with Manufacturing, Quality, R&D, and Regulatory leadership, owns the technology roadmap, vendor management, and data integrity, while ensuring compliance with FDA/GxP and cross-site data residency.

Qualifications

• 10+ years IT leadership in a regulated manufacturing environment (medical device/pharma preferred).
• Experience with MES, GxP validation, and plant-floor IT across regions.
• Knowledge of FDA QSR (21 CFR Part 820) and data residency requirements.

Responsibilities

• Own MES strategy and delivery across six global plant sites, including vendor-managed MES service and SLA.
• Own SAP Manufacturing functional areas (Production Planning, Quality Management).
• Own GxP validation and compliance systems, IQ/OQ/PQ documentation with US sign-off.
• Lead regional Plant IT Engineering teams and manage vendor relationships and contracts.
• Ensure data quality and regulatory technology support for R&D and Regulatory.

Skills

MES ownership

GxP validation

plant IT leadership

vendor management

Education

Bachelor's degree in Information Technology, Engineering, or related field

MBA or advanced degree a plus

Job description

embecta is a global medical device company seeking a Sr. Director, IT-R&D, Manufacturing, Quality, and Regulatory to lead global MES, SAP Manufacturing, GxP validation, and regulatory tech strategy across six plant sites.

The role partners with Manufacturing, Quality, R&D, and Regulatory leadership, owns the technology roadmap, vendor management, and data integrity, while ensuring compliance with FDA/GxP and cross-site data residency.