Director, SDLC, Testing & Release Management
Regeneron
4 months ago
On-site
Troy, NY
IT
Responsibilities:
- Own, develop, and execute the strategic vision for SDLC, CI/CD, testing, release management, and AI-augmented automation enterprise-wide, including deployment and upgrades of GMP IT solutions.
- Establish and govern standardized SDLC processes to ensure consistency, efficiency, speed, and compliance.
- Build, train, and lead an internal IT SDLC team on SDLC and Computer Software Assurance (CSA) processes/requirements; develop test plans and compliant documentation for QA approval.
- Develop test automation frameworks, including LLM- and AI-driven testing; enhance release management for reliability and continuity.
- Lead and mentor a cross-functional organization; partner with QA, Compliance, and Regulatory teams to accelerate implementations and system changes.
- Define and improve quality metrics and KPIs, including AI-enabled indicators.
- Drive modern testing methodologies and AI-assisted validation; establish robust test data management; oversee risk evaluation of emerging technologies including LLMs.
- Ensure compliance with CSA, CSV, Part 11, Annex 11, and GAMP 5; enforce documentation standards including automated draft content generation.
- Serve as primary escalation point and represent test/release functions at executive forums.
Qualifications/Skills (Required/Preferred):
- BS/BA in Information Technology or related field.
- Associate Director: 10+ years in Information Systems/Technology; 8+ years managing employees and budgets; 7+ years in GMP manufacturing; biotech/pharma experience; IT compliance experience per GAMP 5.
- Director: 12+ years in Information Systems/Technology; 10+ years managing employees and budgets; 10+ years in GMP manufacturing; biotech/pharma experience; IT compliance experience per GAMP 5.
- 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, decision-making, risk management, and budget/resource planning; compliance leadership incl. AI-enabled systems.
Application instructions:
- Apply now.
- Own, develop, and execute the strategic vision for SDLC, CI/CD, testing, release management, and AI-augmented automation enterprise-wide, including deployment and upgrades of GMP IT solutions.
- Establish and govern standardized SDLC processes to ensure consistency, efficiency, speed, and compliance.
- Build, train, and lead an internal IT SDLC team on SDLC and Computer Software Assurance (CSA) processes/requirements; develop test plans and compliant documentation for QA approval.
- Develop test automation frameworks, including LLM- and AI-driven testing; enhance release management for reliability and continuity.
- Lead and mentor a cross-functional organization; partner with QA, Compliance, and Regulatory teams to accelerate implementations and system changes.
- Define and improve quality metrics and KPIs, including AI-enabled indicators.
- Drive modern testing methodologies and AI-assisted validation; establish robust test data management; oversee risk evaluation of emerging technologies including LLMs.
- Ensure compliance with CSA, CSV, Part 11, Annex 11, and GAMP 5; enforce documentation standards including automated draft content generation.
- Serve as primary escalation point and represent test/release functions at executive forums.
Qualifications/Skills (Required/Preferred):
- BS/BA in Information Technology or related field.
- Associate Director: 10+ years in Information Systems/Technology; 8+ years managing employees and budgets; 7+ years in GMP manufacturing; biotech/pharma experience; IT compliance experience per GAMP 5.
- Director: 12+ years in Information Systems/Technology; 10+ years managing employees and budgets; 10+ years in GMP manufacturing; biotech/pharma experience; IT compliance experience per GAMP 5.
- 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, decision-making, risk management, and budget/resource planning; compliance leadership incl. AI-enabled systems.
Application instructions:
- Apply now.