Digital Quality Systems Lead

AbbVie Inc.; Tempe (AZ); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Quality Systems Lead to own the lifecycle management and validation of digital quality systems in a regulated environment. You will ensure inspection readiness and partner with Quality, Manufacturing, IT, and Engineering to implement compliant digital solutions.

The role requires a strong background in cGMP, data integrity, and electronic records/electronic signatures, with demonstrated experience in validation and quality-system processes.

Qualifications

• Bachelor's degree in engineering, computer science, life sciences, or a related technical discipline; advanced degree preferred.
• Experience with quality management systems, electronic records systems, manufacturing or laboratory systems, or comparable GxP digital platforms.
• Experience with software or computer system validation, including risk-based validation, requirements, testing, traceability, and validation documentation.

Responsibilities

• Lead Quality ownership of digital quality systems, including implementation, enhancement, lifecycle management, and operational support for quality-related capabilities.
• Act as the Quality system subject-matter expert, translating business, cGMP, data integrity, and electronic records/electronic signatures requirements into clear system requirements and operational controls.
• Partner with Quality, Manufacturing, IT, Engineering, Validation, and other stakeholders to define, configure, test, deploy, and sustain compliant digital solutions.
• Own or coordinate Quality input to software and computer system validation activities, including risk assessments, requirements, test strategy, test execution, traceability, defect resolution, and validation deliverables, as applicable.
• Ensure systems and associated processes support accurate, complete, consistent, contemporaneous, and attributable electronic data and records throughout the data lifecycle.
• Lead Quality review and approval of system changes, releases, access controls, and periodic assessments through established change-control and quality-system processes.
• Support investigation and resolution of system-related deviations, incidents, data-integrity events, and CAPAs; assess product-quality and compliance impact and drive timely, effective actions.
• Develop and maintain procedures, work instructions, training materials, and role-based training to promote compliant and effective use of digital quality systems.
• Monitor system performance, user feedback, and emerging compliance needs; identify and implement continuous improvements in partnership with functional stakeholders.
• Maintain inspection readiness by providing system expertise, validation evidence, traceability, and clear responses to internal audits, regulatory inspections, and health-authority inquiries.

Skills

Excellent communication skills

Independent worker

Education

Bachelor's degree in engineering, computer science, life sciences, or related technical discipline

Job description

AbbVie is seeking a Quality Systems Lead to own the lifecycle management and validation of digital quality systems in a regulated environment. You will ensure inspection readiness and partner with Quality, Manufacturing, IT, and Engineering to implement compliant digital solutions.

The role requires a strong background in cGMP, data integrity, and electronic records/electronic signatures, with demonstrated experience in validation and quality-system processes.