IT Business Partner

The IT Business Partner - Pharmaceutical Manufacturing serves as the strategic technology partner for Manufacturing, Quality, Engineering, and Supply Chain functions within a regulated pharmaceutical environment. This role combines strong business partnership and stakeholder engagement with deep manufacturing IT, solution architecture, and compliance expertise to ensure technology solutions enable safe, compliant, and efficient operations., Business Partnership & Strategy (?50%)

• Act as the primary IT partner for Manufacturing, Quality, Engineering, and Supply Chain leadership
• Build trusted relationships with site leadership, operations managers, quality leaders, and business stakeholders
• Develop a strong understanding of pharmaceutical manufacturing processes, compliance requirements, and operational KPIs
• Translate business and regulatory needs into IT strategies, roadmaps, and prioritized initiatives
• Partner with business leaders to develop business cases, define success metrics, and track value realization
• Align site?level priorities with enterprise IT strategy and governance

Manufacturing IT, Architecture & Compliance (?50%)

Manufacturing & Quality Systems

• Lead IT engagement for manufacturing and quality systems, including MES, LIMS, QMS, EMS, serialization, and plant historians
• Support integration between shop?floor systems (MES, SCADA, PLCs) and enterprise platforms (ERP, data, analytics)
• Ensure systems support GMP manufacturing, batch integrity, traceability, and electronic records

Solution Architecture & Integration

• Provide solution and integration oversight for ERP (e.g., SAP), manufacturing execution, quality, maintenance, and supply chain systems
• Collaborate with enterprise architects to ensure solutions are scalable, secure, and compliant with enterprise standards
• Support digital manufacturing and Industry 4.0 initiatives within a validated pharmaceutical environment

Validation, Data Integrity & Regulatory Compliance

• Ensure IT solutions meet GxP, CSV, and data integrity requirements (e.g., ALCOA+)
• Partner with Quality and Validation teams to support system validation, change control, and audit readiness
• Ensure compliance with FDA, EMA, and other global health authority expectations

Delivery Oversight & Change Enablement

• Serve as the single point of accountability for IT delivery outcomes supporting manufacturing and quality operations
• Identify risks, dependencies, and compliance impacts early and drive mitigation plans
• Lead change enablement activities, including communication, training coordination, and adoption support
• Ensure solutions are effectively embedded into shop?floor and quality processes

• 10+ years of experience in IT roles supporting pharmaceutical or other GxP?regulated manufacturing environments
• Strong understanding of pharmaceutical manufacturing operations and quality systems
• Hands?on experience with manufacturing IT systems (MES, LIMS, QMS, ERP)
• Experience with system validation, data integrity, and regulated change management
• Proven ability to partner with manufacturing, quality, and engineering leadership

Preferred Qualifications

• Experience as an IT Business Partner, Manufacturing IT Lead, or Solution Architect
• SAP experience (PP, QM, PM, MM) or equivalent ERP platforms
• Exposure to serialization, track & trace, or regulatory reporting systems
• Experience supporting multi?site or global pharmaceutical operations
• Knowledge of cybersecurity considerations in OT and regulated environments