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.

As a Director, GxP 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.
• 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.

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.

In order to be considered for this position, you must hold a BS/BA in Information Technology or related field along with

• Associate Director: 10 years of experience in a relevant industry or equivalent combination of education and experience. Biotechnology/Life Sciences industry experience, preferred.
• Director: 12 years of experience in a relevant industry or equivalent combination of education and experience. Biotechnology/Life Sciences industry experience, preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$192,900.00 - $321,100.00