Director, SDLC, Testing & Release Management

Regeneron Pharmaceuticals

32d • Onsite

About The Position

The Director of SDLC, Testing & Release Management will own, develop, and execute the strategic vision for SDLC, CI/CD, testing, release management, and AI‑augmented automation across the enterprise to accelerate digital transformation that includes deployment and upgrades of several GMP IT solutions. As a Director, a typical day might include the following: Establish and govern standardized SDLC processes ensuring consistency, efficiency, speed and compliance. Build, train and guide internal IT SDLC team on SDLC and CSA processes and requirements, development of effective and efficient test plans, compliant documentation ready for QA approval. Serve as the organizational authority for Computer Software Assurance (CSA). Develop test automation frameworks including LLM‑ and AI‑driven testing. Enhance release management processes for reliability and continuity. Lead and mentor a cross‑functional organization, partner with QA, Compliance, and Regulatory teams to accelerate new system implementations and system changes. Define and improve quality metrics and KPIs including AI‑enabled indicators. Drive adoption of modern testing methodologies and AI‑assisted validation, establish robust test data management practices. Oversee risk evaluation of emerging technologies including LLMs. Ensure compliance with CSA, CSV, Part 11, Annex 11, GAMP 5. Enforce documentation standards, including automated draft content generation. Serve as the primary escalation point. Represent test and release functions at executive forums. This role may be for you if you have: CI/CD: Jenkins, GitLab CI, GitHub Actions. Testing: Selenium, JUnit, TestNG, Cypress, Playwright. AI/LLM: testing tools, prompt engineering, model governance. IaC: Terraform, Ansible. Cloud & Containers: Docker, Kubernetes. Monitoring: Prometheus, Grafana, ELK. Version Control: Git, SVN. Work Management: Jira, Confluence, Azure DevOps. Validation Systems: electronic validation platforms. Change‑management leadership with strong decision‑making, risk‑management skills and budget/resource planning. Compliance leadership including AI‑enabled systems.

Requirements

• CI/CD: Jenkins, GitLab CI, GitHub Actions.
• Testing: Selenium, JUnit, TestNG, Cypress, Playwright.
• AI/LLM: testing tools, prompt engineering, model governance.
• IaC: Terraform, Ansible.
• Cloud & Containers: Docker, Kubernetes.
• Monitoring: Prometheus, Grafana, ELK.
• Version Control: Git, SVN.
• Work Management: Jira, Confluence, Azure DevOps.
• Validation Systems: electronic validation platforms.
• Change‑management leadership with strong decision‑making, risk‑management skills and budget/resource planning.
• Compliance leadership including AI‑enabled systems.
• 12+ years working in Information Systems and Technology with 10+ years of managing employees and budgets, 10+ years working in a GMP manufacturing environment and experience in a biotech/pharma environment plus experience with IT Compliance guidelines as per GAMP 5.

Responsibilities

• Establish and govern standardized SDLC processes ensuring consistency, efficiency, speed and compliance.
• Build, train and guide internal IT SDLC team on SDLC and CSA processes and requirements, development of effective and efficient test plans, compliant documentation ready for QA approval.
• Serve as the organizational authority for Computer Software Assurance (CSA).
• Develop test automation frameworks including LLM‑ and AI‑driven testing.
• Enhance release management processes for reliability and continuity.
• Lead and mentor a cross‑functional organization, partner with QA, Compliance, and Regulatory teams to accelerate new system implementations and system changes.
• Define and improve quality metrics and KPIs including AI‑enabled indicators.
• Drive adoption of modern testing methodologies and AI‑assisted validation, establish robust test data management practices.
• Oversee risk evaluation of emerging technologies including LLMs.
• Ensure compliance with CSA, CSV, Part 11, Annex 11, GAMP 5.
• Enforce documentation standards, including automated draft content generation.
• Serve as the primary escalation point.
• Represent test and release functions at executive forums.

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