Global IT Director — Manufacturing, Quality & Regulatory

Embecta Corp.; Milano; On-site; EUR 180,000 - 240,000; Full time

Job summary

embecta is seeking a Sr. Director of IT-R&D, Manufacturing, Quality, and Regulatory to lead MES strategy and delivery across six global plant sites, including SAP Manufacturing and GxP validation programs.

You will steer quality systems, regulatory tooling, and R&D/Regulatory technology roadmaps as scope evolves, while aligning with enterprise standards. Based in the EU with regular worldwide travel, you will manage regional Plant IT Engineering teams and vendor relationships, ensuring data

Qualifications

• 10+ years IT leadership in regulated manufacturing
• Experience with MES, GxP validation, and plant-floor IT
• Global plant IT leadership across regions
• Knowledge of FDA QSR (21 CFR Part 820) and data residency

Responsibilities

• Own MES strategy and delivery across 6 global plant sites
• Lead SAP Manufacturing (Production Planning, Quality Management)
• Own GxP validation and compliance systems (IQ/OQ/PQ)
• Own quality systems across sites
• Oversee R&D tech roadmap and Regulatory tech roadmap as scope matures
• Ensure data quality and system integration across plant, quality, regulatory
• Manage regional Plant IT Engineering teams and vendor relationships
• Ensure OT security collaboration with OT/CISO teams

Skills

MES

GxP validation

Plant IT leadership

SLA management

OT security

R&D tech knowledge

Education

Bachelor's degree in IT/Engineering

MBA or advanced degree

Tools

Rockwell MES

Siemens MES

SAP Manufacturing

Regulatory submission tools

Job description

embecta is seeking a Sr. Director of IT-R&D, Manufacturing, Quality, and Regulatory to lead MES strategy and delivery across six global plant sites, including SAP Manufacturing and GxP validation programs.

You will steer quality systems, regulatory tooling, and R&D/Regulatory technology roadmaps as scope evolves, while aligning with enterprise standards. Based in the EU with regular worldwide travel, you will manage regional Plant IT Engineering teams and vendor relationships, ensuring data