Associate Director of IT Operations (GMP IT/OT)

Role Summary

The Associate Director of IT Operations (GMP IT/OT) ensures the reliable operation, delivery, and management of IT/Operational Technology (IT/OT) infrastructure and services, with a focus on supporting a highly regulated GxP environment. This role provides strategic direction, operational management, and administrative oversight for the daily IT operational activities, including hardware, communications & WiFi infrastructure, and service delivery. The position also ensures integration and alignment with corporate IT systems and infrastructure while maintaining robust compliance, security, and service standards.

Responsibilities

• Ensure the reliable operation of IT/OT infrastructure, including servers, hardware, communications and desktop support, plus oversight of daily operational activities.
• Define, implement, and lead IT/OT infrastructure architecture, with a focus on hyper-converged systems, advanced networking, and wireless technologies, to ensure robust connectivity and security.
• Build scalable and secure wireless networks to support industrial and enterprise needs.
• Provide operational management for data centre operations, network services, telecom, asset management, and security plus ensure systems and procedures are in place for effective monitoring and reporting.
• Maintain compliance with industry standards, including experience with automation systems such as DeltaV/Emerson and Rockwell/Allen-Bradley.
• Manage service providers to ensure high-quality service delivery and alignment to service level agreements (SLAs) and act as the escalation point for major incidents.
• Ensure compliance with relevant regulations and standards, including GxP, FDA and other global regulatory requirements.
• Maintain robust security measures to protect IT/OT infrastructure, including data integrity and disaster recovery planning.
• Lead and mentor a diverse technical team and run recruitment, training, performance evaluations, and target setting for the IT Operations team.
• Collaborate with partners to ensure seamless integration between IT and OT systems.
• Provide regular management reporting on service performance and IT operations.

Qualifications

• BS/BA in Information Technology or related field.
• Senior Manager: 8+ years of progressively more responsible experience, including 8+ years of management experience and a minimum of 3 years’ experience in an FDA or similarly regulated environment.
• Associate Director: 10 years of progressively more responsible experience, including 10 years of management experience and a minimum of 3 years’ experience in an FDA or similarly regulated environment.
• May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.
• Preferred knowledge of IT compliance guidelines, including PICS, CFR21 Part 11, Annex 11, and GAMP.
• Management and delivery experience including management of a diverse technical team, including Helpdesk, Desktop, Server and Network staff; experience managing vendors and managed services.
• Experience in developing and deploying SLAs, metrics, and other ITIL practices.
• Experience with Business Continuity and Disaster Recovery planning.
• Strong background in Microsoft OS, in particular Server and GPO elements.
• Strong understanding of Data Integrity and associated tools.

Skills

• IT/OT infrastructure management
• Hyper-converged architectures, advanced networking, wireless technologies
• Data centre operations, asset management, security
• Regulatory compliance (GxP, FDA) and IT governance
• Vendor management and SLA oversight
• Security, disaster recovery, business continuity
• Team leadership, recruitment, performance management
• ITIL, incident management, and service delivery metrics

Education

• BS/BA in Information Technology or related field