Description
Position Summary:
We are seeking an experienced Enterprise Technology Services Director to lead and oversee all Enterprise Technology functions across the organization, including Information Technology, Operational Technology, Automation, Quality Systems Technology, and Digital Compliance & Validation. This role is responsible for aligning technology strategy with business and manufacturing operations while ensuring secure, compliant, and reliable systems that support production, quality, and enterprise initiatives.
The Enterprise Technology Services Director will provide leadership to cross-functional technology teams, manage enterprise and manufacturing technology operations, and drive continuous improvement, compliance, automation, and digital transformation initiatives.
Primary Responsibilities
- Oversee all technology operations and evaluate performance against established business and operational goals.
- Develop and implement technology strategies, policies, standards, and systems aligned with organizational objectives.
- Analyze business requirements across technology departments to determine enterprise and operational technology needs.
- Identify opportunities for system upgrades, integrations, automation, and infrastructure improvements.
- Coordinate and supervise technology managers, engineers, analysts, and support personnel.
- Build and maintain vendor relationships and cost-effective service agreements.
- Provide leadership to ensure technology services meet performance, reliability, compliance, and cybersecurity expectations.
- Support Lean manufacturing and continuous improvement initiatives utilizing Six Sigma methodologies.
- Lead and support enterprise and manufacturing technology projects.
- Consult with executive leadership and stakeholders to optimize technology utilization and digital strategy.
- Develop standards and processes for the selection, implementation, support, and lifecycle management of systems.
- Analyze local, national, and industry trends impacting technology, manufacturing, compliance, and cybersecurity.
- Collaborate with engineers, programmers, operations, and quality leadership to identify process improvement opportunities and data governance strategies.
Functional Oversight Responsibilities
Operational Technology & Manufacturing Systems
- Provide leadership and strategic oversight for MES, EBR, automation, and manufacturing technology platforms supporting production operations.
- Partner with Operations, Engineering, and Manufacturing leadership to improve system reliability, production efficiency, traceability, and operational performance.
- Support enterprise initiatives involving PharmaSuite, manufacturing system integrations, automation strategies, and ERP connectivity with NetSuite ERP.
- Guide technology teams supporting PLC, SCADA, HMI, MES, and manufacturing data systems to ensure alignment with business and operational objectives.
- Provide operational metrics, project updates, risk assessments, and strategic recommendations to senior leadership regarding manufacturing technology systems and initiatives.
Enterprise Information Technology & Infrastructure
- Provide leadership and oversight for enterprise IT operations including infrastructure, cybersecurity, helpdesk services, end-user support, disaster recovery, and enterprise systems.
- Partner with senior leadership to ensure reliable, secure, and scalable technology services that support business continuity and organizational growth.
- Oversee technology support models, infrastructure performance, cybersecurity programs, enterprise backups, and network reliability.
- Support organizational technology planning, budgeting, vendor management, and infrastructure modernization initiatives.
- Deliver system performance reporting, operational metrics, and strategic technology recommendations to executive leadership.
Quality Systems, Compliance & Validation
- Provide leadership and oversight for quality systems technology, compliance programs, and computer system validation activities.
- Partner with Quality, Regulatory, and Compliance leadership to ensure technology systems support GMP operations, data integrity, audit readiness, and regulatory compliance.
- Oversee support strategies for LIMS, MODA-EM, QMS, and compliance-related systems.
- Guide validation lifecycle activities including IQ/OQ/PQ, change management, documentation management, and 21 CFR Part 11 compliance initiatives.
- Support audits, inspections, investigations, CAPA activities, and regulatory reviews involving enterprise and operational technology systems.
Requirements
Requirements & Qualifications:
Minimum Skills Required:
- Degree in Information Technology, Engineering, Computer Science, Automation, or related field preferred.
- 10+ years of progressive technology leadership experience in manufacturing, pharmaceutical, biotech, or regulated industries preferred.
- Strong understanding of enterprise IT infrastructure, operational technology, automation systems, MES, ERP integrations, cybersecurity, and computer system validation.
- Experience with pharmaceutical or regulated manufacturing systems including MES, EBR, LIMS, SCADA, PLCs, and quality systems preferred.
- Knowledge of FDA, GMP, GAMP5, data integrity, and 21 CFR Part 11 requirements.
- Demonstrated leadership, project management, vendor management, and strategic planning experience.
- Strong communication, organizational, and cross-functional collaboration skills.
Working Conditions / Physical Requirements:
- This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.
