Director, SDLC, Testing & Release Management

Role Summary

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. The role leads a cross-functional team and partners with QA, Compliance, and Regulatory teams to accelerate new system implementations and system changes. It focuses on establishing standardized SDLC processes, enabling AI-enabled testing, and robust release management.

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.

Skills

• 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.

Qualifications

• 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.

Education

• BS/BA degree in Information Technology or related field.