Job DescriptionThe Principal Digital Regulatory Assurance is responsible for ensuring that AbbVie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role provides leadership in defining, implementing, and optimizing quality systems through digital enablement and AI-driven solutions, and involves direct collaboration with cross-functional teams, Business stakeholders, and the Business Technology Services (BTS) Quality organization. This techno-functional expert transforms traditional quality assurance by implementing automation frameworks and DevOps best practices that enhance efficiency, reduce cycle times, and ensure regulatory compliance while optimizing CI/CD pipelines
The Principal Digital Regulatory Assurance will provide oversight of quality activities, especially across Technology Lifecycle process monitoring and incident management, drive improvement initiatives, troubleshoot IT quality issues, and support all phases of the IT solution lifecycle. The incumbent acts as the primary point of contact between business units and quality teams, ensuring mutual understanding of needs and maintaining effective service agreements.
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 DevOps process and toolchain expertise to standardize, streamline, and simplify DevOps 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 DevOps 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.
QualificationsRequired:
- Bachelor's degree plus 7 years of experience, master's degree plus 6 years of experience, PhD plus 2 years of experience.
- Proven expertise in DevOps toolchains (e.g., Jira, Confluence, qTest, Jenkins, GitLab, AWS and Azure DevOps), 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:
- Proven expertise in DevOps toolchains (e.g., Jira, Confluence, qTest, Jenkins, GitLab, AWS and Azure DevOps), automation pipelines, and CI/CD in life sciences industry.
- Supervisory experience.
- Professional certifications (e.g., ASQ CQA, PMP, Six Sigma).
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- 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 on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
