Director, GMP Enterprise Architecture

Regeneron Pharmaceuticals

8d • Onsite

About The Position

The Director, GMP Enterprise Architecture leads the IT architecture practice for manufacturing and operations (e.g., manufacturing, QA, QC, process sciences, supply chain). This role defines technology strategy and standards, governs platform decisions, and ensures solutions meet GMP and data integrity requirements while advancing business capabilities and long-term platform health. As a Director, GMP Enterprise Architecture, a typical day might include the following: Define and evolve EA governance, standards, reference architectures, and reusable patterns across application, integration, data, and infrastructure. Own the multi-year technology roadmap aligned to business capability priorities and lifecycle plans. Lead architecture reviews, maintain the application portfolio, and manage technical debt and end‑of‑life risk. Ensure alignment with enterprise-wide architecture, avoid redundant platform investments while identifying capability gaps. Translate market trends (ERP, MES, LIMS, QMS, data, cloud, integration) into actionable guidance and adoption plans. Communicate manufacturing strategy, options, and trade-offs to technology and business leaders, to ensure alignment with Corporate IT Enterprise Architecture. Embed GMP, 21 CFR Part 11, Annex 11, data integrity, and CSV/CSA requirements into standards, governance, and change control. Produce and maintain target-state architectures, capability maps, roadmaps, solution blueprints, integration diagrams, and ADRs. This role may be for you if you have knowledge in: GMP systems landscape: ERP (e.g., Oracle EBS, Oracle Fusion), MES, LIMS/ELN, QMS, WMS, EDMS; familiarity with SCADA/DCS and shop-floor integration. Integration patterns and platforms: APIs, event-driven architecture, EDI, ETL/ELT; iPaaS/ESB (e.g., MuleSoft, Boomi), OPC UA; canonical data models. Data and analytics: data lakehouse (e.g., Snowflake, Databricks), MDM, data governance, metadata lineage, BI platforms; ISA-95 data layers. Cloud and infrastructure: AWS/Azure services, hybrid architectures, VPC/VNet design, containerization (Kubernetes), IaC (Terraform), CI/CD, microservices. Security and compliance: identity and access management (Azure AD), segregation of duties, network segmentation/OT boundary patterns, NIST/ISO 27001 controls, backup/DR. Architecture practice: TOGAF/ArchiMate, modeling tools (e.g., LeanIX, Lucidchart), solution blueprinting, ADRs, and traceability for audits. SDLC and delivery: Agile/SAFe, DevOps in regulated environments, validation documentation (URS/FS/DS), risk-based CSA.

Requirements

• BS/BA in Information Technology or related field
• 12 years of experience in a relevant industry or equivalent combination of education and experience
• Knowledge in: GMP systems landscape: ERP (e.g., Oracle EBS, Oracle Fusion), MES, LIMS/ELN, QMS, WMS, EDMS; familiarity with SCADA/DCS and shop-floor integration.
• Integration patterns and platforms: APIs, event-driven architecture, EDI, ETL/ELT; iPaaS/ESB (e.g., MuleSoft, Boomi), OPC UA; canonical data models.
• Data and analytics: data lakehouse (e.g., Snowflake, Databricks), MDM, data governance, metadata lineage, BI platforms; ISA-95 data layers.
• Cloud and infrastructure: AWS/Azure services, hybrid architectures, VPC/VNet design, containerization (Kubernetes), IaC (Terraform), CI/CD, microservices.
• Security and compliance: identity and access management (Azure AD), segregation of duties, network segmentation/OT boundary patterns, NIST/ISO 27001 controls, backup/DR.
• Architecture practice: TOGAF/ArchiMate, modeling tools (e.g., LeanIX, Lucidchart), solution blueprinting, ADRs, and traceability for audits.
• SDLC and delivery: Agile/SAFe, DevOps in regulated environments, validation documentation (URS/FS/DS), risk-based CSA.

Responsibilities

• Define and evolve EA governance, standards, reference architectures, and reusable patterns across application, integration, data, and infrastructure.
• Own the multi-year technology roadmap aligned to business capability priorities and lifecycle plans.
• Lead architecture reviews, maintain the application portfolio, and manage technical debt and end‑of‑life risk.
• Ensure alignment with enterprise-wide architecture, avoid redundant platform investments while identifying capability gaps.
• Translate market trends (ERP, MES, LIMS, QMS, data, cloud, integration) into actionable guidance and adoption plans.
• Communicate manufacturing strategy, options, and trade-offs to technology and business leaders, to ensure alignment with Corporate IT Enterprise Architecture.
• Embed GMP, 21 CFR Part 11, Annex 11, data integrity, and CSV/CSA requirements into standards, governance, and change control.
• Produce and maintain target-state architectures, capability maps, roadmaps, solution blueprints, integration diagrams, and ADRs.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees