Principal Digital Regulatory Assurance Engineer

Company Description

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us  Follow @abbvie onLinked

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Job Description

The Principal Digital Regulatory Assurance is responsible for ensuring that Abb Vie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This roleprovidesleadership in defining, implementing, andoptimizingquality 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 Dev Ops best practices that enhance efficiency, reduce cycle times, and ensure regulatory compliance whileoptimizingCI/CD pipelines

The Principal Digital Regulatory Assurance will provide oversight of quality activities, especially across Technology Lifecycle processmonitoringand 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 andmaintainingeffective service agreements.

Key Responsibilities:

• Develop, implement, and champion solution/change strategies that align with organizationalobjectivesand evolving regulatory requirements,leveraging AI-powered solutions and automation to enhance compliance monitoring and operational efficiency.

• Leverage extensive Dev Ops process and toolchainexpertiseto standardize, streamline, and simplify Dev Ops practices by integrating andoptimizingtools 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 andalertsfor system performance, and implement targeted improvements to ensureoptimalcompliance 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, ensuringtimelyimplementation 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 tomaintaincompliance andfacilitateinvestigations 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, submittimelyrisk assessments tomaintaincompliance and business continuity.

• Develop,monitor, and interpret SQA metrics and trends using automated analytics,identifyingqualitygapsand preparing actionable dashboards and reports for senior leadership.

Qualifications

Required:

• Bachelor’s degree plus 7 years of experience, master’s degree plus 6 years of…