Associate Director, Digital Manufacturing Systems & Operations It

Merck Merck · Pharma · North Brabant, Netherlands

Associate Director, Digital Manufacturing Systems & Operations IT at Merck, leading a team responsible for delivering, operating, and managing digital and capital systems supporting GMP manufacturing in a highly regulated biotechnology environment. Focuses on digital transformation, system lifecycle management, and leveraging data and analytics for site performance improvement.

What you'd actually do

  1. Lead an agile team of application specialists to ensure reliable, compliant system operations supporting biotechnology manufacturing.
  2. Own stable operation of site applications, including maintenance, upgrades, spares, disaster recovery, and contingency planning.
  3. Define, measure, and continuously improve system and team performance using data-driven metrics.
  4. Develop and maintain an effective site systems support model, integrating vendors, third parties, and global IT/DTI teams with clear accountability.
  5. Manage all planned and unplanned application outages and hold full accountability for GMP-critical systems (Quality, LIMS/LMES, SAP, MES, historians, analytics).

Skills

Required

  • Doctorate degree in Engineering, Information Systems, Computer Science, or Life Sciences with 2 years of relevant experience; or Master’s degree in Engineering, Information Systems, Computer Science, or Life Sciences with 6 years of relevant experience; or Bachelor’s degree in Engineering, Information Systems, Computer Science, or Life Sciences with 8 years of relevant experience.
  • Proven experience delivering high-quality support for manufacturing systems in a regulated GMP environment, preferably within biologics or pharmaceutical industries.
  • Minimum of 5 years of people management experience, leading and implementing digital innovation at site or network level.
  • Demonstrated experience leading or supporting regulatory inspections, audits, or health authority interactions.
  • Prior experience or certification in ITIL, Agile, or SCRUM methodologies is required.
  • Strong analytical and problem-solving capabilities with a data-driven mindset.
  • In-depth knowledge of GMP, 21 CFR Part 11 / Annex 11, data integrity, validation processes, and compliance requirements.
  • Certified in or experienced with Scaled Agile Framework (SAFe) or agile product team environments.

Nice to have

  • SAP / S/4HANA
  • MES (PAS‑X)
  • CDS Empower
  • LIMS
  • Data Historians
  • Automation systems
  • Laboratory systems
  • Robotic Process Automation (RPA)
  • Machine Learning & Artificial Intelligence
  • Data analyt

What the JD emphasized

  • highly regulated manufacturing environment
  • highly regulated GMP environment
  • compliance standards within biotechnology or similarly regulated industries
  • In-depth knowledge of GMP, 21 CFR Part 11 / Annex 11, data integrity, validation processes, and compliance requirements.