Director, GxP Enterprise Architecture

The Director, GxP 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 GxP and data integrity requirements while advancing business capabilities and long‑term platform health.

Typical Day / 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.

Knowledge & Experience

• 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.

Qualifications

Must hold a BS/BA in Information Technology or related field along with 12 years of experience in a relevant industry or an equivalent combination of education and experience. Biotechnology/Life Sciences industry experience is preferred.

Salary

Salary Range (annually) $192,900.00 – $321,100.00

Benefits

• Health and wellness programs (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 (military and parental)

Location & Work Requirements

Many Regeneron roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regeneron's on‑site policy and expectations for your role and location.

Equal Opportunity Employer Statement

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

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