Principal Engineer, Digital Regulatory Assurance (Life Sciences)
Core
Ensures IT operations and software lifecycle compliance with regulatory requirements using AI-driven solutions and automation.
Role type
Principal Digital Regulatory Assurance Engineer (Life Sciences)
Builds
Automated validation tools, intelligent documentation, CI/CD pipelines, and compliance dashboards
Domain
Life Sciences / Regulatory Technology / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis
Required skills
DevOps toolchains, CI/CD pipeline optimization, SQA practices, validation strategy, risk management, incident management, regulatory audit support, analytics, project management, process improvement, cross-functional collaboration, team coaching, Computer Software Assurance (CSA), digital transformation in quality
Preferred skills
Life sciences industry DevOps expertise, supervisory experience
Technologies
Jira, Confluence, qTest, Jenkins, GitLab, AWS, Azure DevOps
Responsibilities
Develop and champion solution strategies aligning with regulatory requirements; Leverage DevOps expertise to standardize and optimize CI/CD pipelines; Lead continuous improvement of quality assurance frameworks; Drive automation of Software Lifecycle processes; Manage technology lifecycle process monitoring and incident management; Represent SQA on strategic forums and regulatory engagements; Support regulatory audits and CAPA investigations; Provide expert mentorship on DevOps and quality technologies; Lead training initiatives on IT Quality standards; Oversee documentation and evidence management; Escalate and resolve significant quality exceptions; Engage in infrastructure change management and risk review; Develop and monitor SQA metrics using automated analytics
Seniority
Principal, hands-on IC with strategic leadership