Director, GxP Enterprise Architecture

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.
• Manage business strategy enablement options, and trade‑offs met by technology with business leaders.
• Collaborate with corporate IT's Architecture team to ensure architectural standards are in place and enforced.
• Ensure Architecture Standards are aligned with 21 CFR Part 11, Annex 11, data integrity, and CSV/CSA requirements.
• Produce and maintain target-state architectures, capability maps, roadmaps, solution blueprints, integration diagrams, and ADRs.

Qualifications

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

Salary Range

$192,900.00 - $321,100.00

Equal Employment Opportunity Statement

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sex, sexual orientation, gender identity or expression, gender reassignment, age, nationality, marital status, citizenship, disability, military status or any other protected characteristic in accordance with applicable laws and regulations. The Company will provide reasonable accommodation for qualified candidates with well‑documented disabilities, unless the accommodation would impose undue hardship on the operation of the business.

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