Principal Engineer, Quality Assurance, Dev-Ops

Principal Engineer, Quality Assurance, Dev-Ops

Salary Min: 109500 Salary Max: 208500

Full-time | Workday Global Grade: 18 | Travel:
Yes, 5% of the Time

Key Responsibilities:

• Develop, implement, and champion solution/change strategies that align with organizational objectives and evolving regulatory requirements, leveraging AI-powered solutions and automation to enhance compliance monitoring and operational efficiency.
• Leverage extensive Dev Ops process and toolchain expertise to standardize, streamline, and simplify Dev Ops practices by integrating and optimizing tools across CI/CD pipelines, automated testing, deployment, and monitoring capabilities.
• Lead continuous improvement and digital enablement initiatives, focusing on modernizing quality assurance frameworks and driving adoption of advanced automation, validation pipelines, and intelligent process monitoring.
• Drive automation of Software Lifecycle (SLC) processes by developing and deploying automated validation tools, intelligent documentation generation, and workflow solutions to reduce manual effort and cycle times.
• Manage technology lifecycle process monitoring, establish automated dashboards and alerts for system performance, and implement targeted improvements to ensure optimal compliance and efficiency.
• Serve as the primary point of contact for incident management related to quality events and deviations, coordinate investigations, root cause analysis, and ensure effective corrective actions.
• Monitor and update SLC procedures in response to changes in regulatory standards and industry best practices.
• Represent SQA on strategic forums, steering committees, and regulatory engagements; communicate quality outcomes, audit results, and improvements to partners and stakeholders.
• Support and manage regulatory audits and inspections, oversee CAPA investigations and remediation activities, ensuring timely implementation and closure.
• Provide expert mentorship on Dev Ops best practices, automation, computerized system quality, policy interpretation, and new quality technologies.
• Lead training initiatives for internal teams and business stakeholders on IT Quality standards, SLC procedures, and new tools/technologies.
• Oversee documentation and evidence management to maintain compliance and facilitate investigations and audit readiness.
• Assist Center of Excellence (CoE) leadership with SLC communications, newsletters, and internal coordination efforts.
• Escalate and resolve significant quality exceptions, risks, and issues with minimal supervision.
• Engage in infrastructure change management and risk review activities, submit timely risk assessments to maintain compliance and business continuity.
• Develop, monitor, and interpret SQA metrics and trends using automated analytics, identifying quality gaps and preparing actionable dashboards and reports for senior leadership.

Required Qualifications:

• Bachelor’s degree plus 7 years of experience, master’s degree plus 6 years of experience, or PhD plus 2 years of experience.
• Proven expertise in Dev Ops tool chains (e.g., Jira, Confluence, qTest, Jenkins, Git Lab, AWS, Azure Dev Ops), automation pipelines, and CI/CD.
• Experience managing SQA practices, validation strategy, risk and incident management/mitigation.
• Experience supporting regulatory audits and compliance (FDA or similar agencies).
• Strong skills in analytics, project management, process improvement, and cross-functional collaboration.
• Ability to coach teams in policy, SLC execution, and regulatory requirements.
• Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices.
• Professional certifications (e.g., ASQ CQA, PMP, Six Sigma) preferred.

Preferred Qualifications:

• Proven expertise in Dev Ops tool chains within the life sciences industry.
• Supervisory experience.
• Professional certifications (e.g., ASQ CQA, PMP, Six Sigma).

Compensation: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend…