Associate Director, Digital Manufacturing Systems & Operations It

Merck & Co., Inc.

Boxmeer, Netherlands
Competitive salary; 3% year-end allowance; annual ...
Hybrid
Gmp compliant manufacturing environment
Sap s/4hana and mes systems
Regulatory audit and inspection support
This role leads a team responsible for delivering high-quality, reliable, and compliant operational support for manufacturing systems in a highly regulated GMP environment

Job Summary

  • This role leads a team responsible for delivering high-quality, reliable, and compliant operational support for manufacturing systems in a highly regulated GMP environment.
  • The successful candidate will define and execute a 3–5-year digital transformation roadmap aligned with business objectives while maintaining direct ownership of operational outcomes.
  • Candidates must demonstrate deep understanding of compliance standards within biotechnology and possess excellent communication skills to translate complex technical concepts into clear business impact.

Matching Summary

This role leads a team responsible for delivering high-quality, reliable, and compliant operational support for manufacturing systems in a highly regulated GMP environment.

Salary

Competitive salary; 3% year-end allowance; Annual bonus based on performance

Skills & Requirements

Must-have

  • GMP compliant manufacturing environment
  • SAP S/4HANA and MES systems
  • Regulatory audit and inspection support
  • Agile product team leadership
  • Data integrity and validation processes
  • Application lifecycle management
  • CAPEX/OPEX budget management

Nice-to-have

  • Machine Learning and AI experience
  • Robotic Process Automation knowledge
  • IIoT and AR/VR familiarity
  • Scaled Agile Framework certification
  • Advanced analytics tools proficiency
  • Continuous improvement culture
  • Strategic stakeholder engagement

Key Requirements

  • Master's degree with 6 years experience or Bachelor's with 8 years
  • Minimum 5 years people management experience
  • Experience leading regulatory inspections and audits
  • Certification or experience in ITIL, Agile, or SCRUM
  • In-depth knowledge of 21 CFR Part 11 / Annex 11

Work Rights

Not specified

Tailored Resume

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