Principal Engineer, Digital Regulatory Assurance (Life Sciences)
About The Position
The Principal Quality Engineer – Digital Regulatory Assurance provides regulatory assurance and quality oversight for IT applications, infrastructure platforms, and technology solutions in a regulated life sciences environment. The role is a senior subject matter expert in Software Lifecycle (SLC) processes, Computer Software Assurance (CSA), infrastructure qualification, regulatory compliance, and quality risk management. The position modernizes quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions to improve compliance effectiveness, streamline SLC activities, and strengthen inspection readiness. It connects regulatory requirements with technology solutions and process improvements, enabling AI, automation, and data metrics. The role also represents SQA in governance forums, audits, inspections, and strategic initiatives, and coaches practitioners and project teams.
Requirements
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related discipline with 7 years of experience; or a master’s degree with 6 years of experience; or a PhD with 2 years of experience.
- Strong experience in process optimization, AI-enabled solutioning, audit readiness, CAPAs, and using or supporting DevOps tools and pipeline technologies.
- Experience supporting regulatory audits or inspections and implementing quality monitoring solutions.
- Project management, analytical, and documentation skills, including the ability to create knowledge materials and coach diverse audiences.
- Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices.
- Expert knowledge of GxP regulations.
Nice To Haves
- Master’s degree with a minimum of 6 years of supervisory experience.
- Knowledge of other regulatory domains such as SOX, Privacy, Security, and AI/ML.
- Professional certifications such as ASQ CQA, PMP, or Six Sigma.
Responsibilities
- Provide quality and regulatory oversight for GxP-relevant applications, infrastructure platforms, and technology solutions throughout the Software Lifecycle, ensuring compliance with regulatory requirements, company standards, and quality expectations.
- Advise on SLC, Computer Software Assurance, validation, infrastructure qualification, risk management, and regulatory compliance.
- Lead compliance monitoring activities across assigned portfolios, including periodic reviews, audit trail reviews, validation health assessments, quality metrics, and lifecycle health reporting.
- Partner with business and technology teams to integrate quality, compliance, and validation requirements into the design, implementation, deployment, and ongoing support of technology solutions.
- Guide validation strategies, risk assessments, regulatory characterizations, deviations, CAPAs, audit observations, and other quality-related decisions.
- Lead audit and inspection readiness, including preparation, evidence reviews, stakeholder coaching, audit support, and remediation planning.
- Drive CAPA and audit action management, promoting effective root cause analysis, sustainable corrective actions, timely implementation, and effectiveness verification.
- Monitor evolving regulatory requirements, industry trends, and quality practices and translate them into practical lifecycle process and compliance program improvements.
- Serve as the primary SQA point of contact for digital process improvement initiatives, identifying opportunities for standardization, automation, simplification, and AI enablement.
- Manage automation and AI opportunities, working with stakeholders and technical teams to prioritize, implement, and encourage adoption of solutions that improve quality and compliance outcomes.
- Develop and maintain quality dashboards, compliance scorecards, key risk indicators, and executive reporting on compliance health, operational performance, and emerging risks.
- Facilitate governance reviews and cross-functional discussions to drive accountability, resolve compliance concerns, and support consistent application of quality and regulatory expectations.
- Coach and mentor practitioners and project teams on lifecycle execution, CSA principles, validation expectations, inspection readiness, and quality risk management.
- Represent SQA in governance forums, audits, inspections, and strategic initiatives, communicating risks, trends, and recommendations to business stakeholders and leadership.
- Lead continuous improvement efforts that strengthen quality processes, enhance compliance monitoring, and support AbbVie's digital quality transformation.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
