Title: Operation Technology Manager, Region NA. Reports to: Head, Product Services, Operations and Compliance Location: East Windsor, NJ About the Role The Operation Technology Manager is responsible for overseeing all manufacturing and shop-floor IT systems within a GMP-regulated pharmaceutical environment. This role ensures uptime, compliance, and integration across Production, Packaging, Serialization, Quality, Engineering, Supply Chain, Labs, and EHS. The leader will support machine-level operations, drive digital transformation, and ensure strict adherence to GxP and data integrity requirements. This role will be responsible for IT/OT systems across all manufacturing sites across Minnesota, Wisconsin, and New Jersey. Responsibilities 1. Manufacturing Systems & Shop-Floor Technology • Own and evolve a portfolio of critical manufacturing systems — MES, ERP integrations, LIMS, QMS, data historians, SCADA/DCS — ensuring they are stable, validated, and business-enabling. • Provide hands-on line support for production and packaging equipment: HMIs, scanners, printers, weigh scales, robotics, vision systems, batch controllers, and line integration technology. • Drive real-time troubleshooting on the production floor; build escalation frameworks that get issues resolved fast and root causes documented properly. • Serve as the accountable IT-OT owner for all manufacturing system change control, vendor management, and lifecycle planning. 2. Serialization & Track-and-Trace • Lead OT oversight for end-to-end serialization across all packaging lines — from equipment configuration through regulatory submission. • Manage Level 2–4 serialization systems (Antares, Systech, Tracelink, Optel) and ensure seamless integration with ERP, Quality, and regulatory data flows. • Own DSCSA, EU FMD, and global serialization compliance — partnering closely with Quality and Supply Chain to maintain audit readiness and full traceability at all times. • Proactively identify serialization risks; communicate them clearly to leadership and mobilize cross-functional response before they become audit findings. 3. GMP Compliance, CSV & Data Integrity • Set and sustain the standard for GMP, cGMP, and GAMP 5 compliance across all manufacturing and lab systems — this is a non-negotiable foundation, not a checkbox. • Lead Computer System Validation (CSV) end-to-end: URS, FS, DS, IQ/OQ/PQ, periodic reviews, and change control — building capability in the team to reduce cycle time without compromising quality. • Uphold ALCOA+ principles for data integrity and electronic records; maintain readiness for 21 CFR Part 11, Annex 11, and applicable QC/QA processes across all sites. • Act as a trusted voice in Quality forums — capable of explaining technical risk in plain language and proposing pragmatic, compliant solutions. 4. Cross-Functional Leadership & Stakeholder Partnership • Operate as the primary IT-OT executive partner for Production, Packaging, Quality, QC Labs, Warehouse, Engineering, Maintenance, EHS, and Supply Chain — building relationships grounded in trust, transparency, and delivery. • Lead business engagement forums, prioritization councils, and change control boards — facilitating alignment across functions with competing priorities and timelines. • Translate operational pain points into digital roadmaps and executable programs of work; communicate progress, risks, and decisions in a way that resonates with both plant-floor supervisors and the C-suite. • Proactively surface cross-functional dependencies, resolve conflicts early, and ensure no critical initiative stalls because stakeholders aren't aligned. • Represent IT in regulatory inspections, customer audits, and internal quality reviews — with the confidence and credibility to speak to systems, processes, and controls under scrutiny. 5. Digital Transformation & Continuous Improvement • Drive Pharma 4.0 initiatives: paperless batch records, digital logbooks, automated reporting, IoT sensors, machine connectivity, and AI-based intelligence on the shop floor. • Lead system upgrades, migrations, and integrations for manufacturing and packaging platforms • Vendor & Contract Management - manage vendor relationships, contracts, SLAs, and performance reviews. • Identify and champion continuous improvement opportunities; build a culture where the team doesn't just support the status quo but actively makes it better. • Benchmark against pharma industry best practices and bring external perspective and innovative thinking into manufacturing IT/OT strategy. 6. OT Infrastructure & Cybersecurity • Oversee plant networks, servers, manufacturing VLANs, and segregated OT environments — in close partnership with the corporate Network and Security teams. • Ensure cybersecurity compliance for connected manufacturing equipment, SCADA systems, and serialization infrastructure; own OT/IT segmentation and patch governance for the manufacturing environment. • Align with corporate IT on patching cadence, backups, disaster recovery, and user access governance — acting as the bridge between OT realities and corporate security policy. 7. Operational Support & Incident Management • Provide real-time, decisive support during batch execution failures, packaging line downtime, serialization events, and lab workflow disruptions — the team looks to you to set the tone under pressure. • Build and maintain a structured 24/7 on-call rotation model to ensure coverage across all sites; ensure escalation paths are clear, response SLAs are met, and every incident drives a learning. • Establish post-incident review discipline — RCA, corrective action, and closure — so the same issue never brings a line down twice. 8. Team Leadership & Organizational Development • Lead, inspire, and develop a team of shop-floor /OT analysts, automation support engineers, and system administrators across the North America region. • Build individual capability roadmaps for team members — investing in GMP systems knowledge, shop-floor automation, integration expertise, and CSV skills. • Set high standards and hold the team to them —create an environment where people feel safe raising issues early, taking calculated risks, and are continuously learning. • Foster a culture of compliance, urgency, and continuous improvement; model the behaviors you want to see and recognize them when you see them in others. • Build, lead, and sustain a high-performing manufacturing IT organization by recruiting and retaining top talent, securing the resources needed to achieve strategic objectives, and driving succession planning, talent development, and capability building to support long-term organizational growth and continuity. Skills / Competencies • Demonstrates strong operational and technical leadership, applying a disciplined, data-driven approach to problem-solving, investigations, compliance activities, and business priorities. • Builds credibility and trust through proactive communication, ensuring stakeholders are informed, aligned, and confident in project progress, risks, and outcomes. • Leads teams with a strong sense of accountability and ownership, fostering a culture that anticipates issues, drives timely resolution, and continuously improves performance. • Maintains a high level of compliance and operational readiness by ensuring systems, documentation, processes, and team practices consistently meet regulatory and business requirements. • Identifies opportunities to improve processes, systems, and ways of working, leveraging technology and automation to increase efficiency, reliability, and business value. • Develops and coaches team members, creating an environment that supports engagement, capability building, knowledge sharing, and career growth. • Effectively prioritizes competing demands and resources, balancing day-to-day operational needs with strategic initiatives and organizational objectives. • Collaborates cross-functionally to align IT solutions with manufacturing, quality, engineering, and business goals, driving successful outcomes through partnership and influence. Qualifications/ Requirements • Bachelor's degree in Information Technology, supply chain, , Regulatory Affairs, or Manufacturing,, Engineering, advanced degree a plus. • 10+ years of experience in pharmaceutical serialization, Tracelink, or EPCIS-based systems • 4 years in a leadership role managing cross-functional programs and teams • Deep expertise across MES, ERP (SAP preferred), LIMS, QMS, SCADA/DCS, serialization platforms (Tracelink, Optel,, and shop-floor integration technologies. • Proven GMP compliance credentials: hands-on CSV experience (GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+) and a track record of sustaining compliance across multiple sites and audits. • Travel: up to 30% between sites in MN, WI and NJ