Description

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.

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

Associate Director: 10 + years industry experience in Information Systems and Technology with 8+ years of managing employees and budgets, 7+ years of experience in a GMP manufacturing environment and experience in a biotech/pharma environment plus experience with IT Compliance guidelines as per GAMP 5.
Director: 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.
May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s 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 your location.

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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$147,800.00 - $286,900.00

Director, SDLC, Testing & Release Management

Description

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