Director of IT Operations

About the Business:

Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

The Director IT Operations plays a pivotal role in leading and overseeing the successful implementation and execution of a large-scale, cross-functional IT strategy across the organization. This role will be responsible for developing and executing comprehensive IT operations strategies that align with overall business objectives, overseeing the implementation of new technologies, managing IT infrastructure, and ensuring the stability, security, and efficiency of IT systems while collaborating with key stakeholders to drive continuous improvement and innovation within the IT operations department

Key Responsibilities:

Develop and implementation of I&OT systems and Strategy:

• Support the development of the program’s vision, mission, and strategic objectives.
• Align IT goals with the organization’s overall strategy.
• Provide leadership and guidance to cross-functional leaders and teams.
• Collaborate with cross-functional stakeholders to design, develop, and maintain IT infrastructure and needs in GMP and non-GMP areas.

Develop policies and innovative computerized solutions to achieve results:

• Identify and manage all technology-related system integrations across different software platforms and systems such as Asset Management System, Active
• Monitoring System, Operator Management and Access Control System, Alarm Management System, Disaster Recovery System, Historians.
• Develop and implement strategies to ensure data integrity and compliance across IT systems.
• Lead, develop, review, and approve detailed specifications, engineering documents, SOPs, test scripts, and engineering standards in compliance with site procedures and industry standards.

Stakeholder Engagement:

• Foster strong relationships with internal and external stakeholders.
• Communicate program progress, challenges, and successes to stakeholders and senior leadership.
• Ensure alignment of program objectives with stakeholder expectations.

Resource Management:

• Allocate resources effectively to support IT initiatives.
• Manage program budgets and financial resources.
• Identify opportunities for resource optimization and cost savings.

Quality Assurance:

• Establish and support IT best practices and standards.
• Ensure that deliverables meet quality standards and compliance requirements.
• Implement continuous improvement and lessons learned initiatives to enhance efficiency and effectiveness.

Team Leadership and Development:

• Build and lead high-performing teams.
• Provide coaching and mentorship to managers and team members.
• Articulate a clear and compelling vision aligned with the global cultural tenets and strategic objectives of the company.
• Promote a collaborative and inclusive work culture within the teams.
• Educate other IT and automation colleagues in the site technologies, IT procedures, and industry standards.

Reporting and Documentation:

• Prepare regular status reports for executive leadership.
• Maintain comprehensive documentation and records.
• Evaluate outcomes and identify areas for improvement.

Technical & Functional Skills

• Executive presence and exceptional presentation skills.
• Advanced skills in Microsoft Excel, PowerPoint and Word and comfort with large variety of online meeting tools and AV equipment.
• Excellent written, oral and interpersonal communication skills
• Demonstrated history of teamwork and cross functional collaboration
• Ability to speak English (French and/or German a plus)
• Experience in an international setting preferred.
• Experience with cybersecurity frameworks and standards (e.g., NIST, IEC 62443).
• Demonstrated experience with designing and integrating complex OT systems with IT.
• Demonstrated experience with integrating multiple IT systems to drive operational and security objectives.
• Knowledge of the Medical Device regulations (ISO13485, ISO 14971, 21CFR 820)
• Programming Switches, Firewalls, and custom scripts.
• Experience with Thin Clients, SQL Server design, implementation, and support.
• Certifications such as IEC62443, GICSP or PMP (Project Management Professional) are advantageous.
• Programming Switches, Firewalls, and custom scripts.
• Experience with Thin Clients, SQL Server design, implementation, and support.

Education

• Bachelor’s Degree – 4-year undergraduate degree in Information Technology or equivalent.
• MBA or higher education. Preferred

Experience

• 15+ years minimum experience of direct IT/OT management within Pharmaceutical / Medical Device industry. Required
• 7 years minimum industry experience. Required
• 2-3 years leadership experience in managing a team and/or function. Required

Preferred Qualifications:

• Master’s degree in Engineering or a related discipline is highly desirable.
• Certification of Project Management (ie. PMP, etc.).

Travel Requirements:

• 25-30 % Travel