Digital Quality Engineer: GxP Validation & Compliance

Regulatory Jobs; Tempe (AZ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits package

Short-term incentive programs

Paid time off

Job summary

AbbVie seeks a Quality owner for digital quality systems to ensure compliant data lifecycle management and inspection readiness. You will work with Quality, Manufacturing, IT, and Validation to define requirements, validate systems, and sustain controls across the lifecycle.

Ideal candidates have 5+ years in regulated environments, experience with electronic records and software validation, and strong communication skills for training and procedures.

Qualifications

• 5+ years of experience in pharmaceutical/regulated manufacturing environments.
• Experience with quality management systems and electronic records.
• Ability to write procedures and training materials.

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

Quality systems expertise

Data integrity

Regulatory compliance

Education

Bachelor's degree in engineering or related field

Tools

Software validation

Job description

AbbVie seeks a Quality owner for digital quality systems to ensure compliant data lifecycle management and inspection readiness. You will work with Quality, Manufacturing, IT, and Validation to define requirements, validate systems, and sustain controls across the lifecycle.

Ideal candidates have 5+ years in regulated environments, experience with electronic records and software validation, and strong communication skills for training and procedures.