Digital Quality Engineer: Compliance & Validation Lead

AbbVie; Tempe (AZ); On-site; USD 110,000 - 170,000; Full time

Job summary

AbbVie is seeking a qualified professional to own the lifecycle management, validation, and sustained operation of digital quality systems. You will serve as the Quality subject‑matter expert for digital quality technologies, ensuring systems are compliant, inspection‑ready, and aligned with cGMP and data integrity requirements.

The role requires collaboration across Quality, Manufacturing, IT, Engineering, and Validation to define, configure, test, deploy, and sustain compliant digital

Qualifications

• Minimum 5 years in regulated manufacturing or pharma environments.
• Experience with quality management and electronic records systems.
• Ability to translate regulatory requirements into system specifications.

Responsibilities

• Lead Quality ownership of digital quality systems, including implementation and lifecycle management.
• Serve as Quality subject‑matter expert for digital quality technologies.
• Collaborate with Quality, Manufacturing, IT and Engineering to deploy compliant digital solutions.
• Own or coordinate validation activities including risk assessments, requirements, tests, and traceability.
• Ensure data integrity and auditable records across the data lifecycle.
• Lead change controls, access governance, and periodic system assessments.
• Support investigations of deviations and CAPAs related to systems.

Skills

Communication skills

Independent worker

Stakeholder influence

Written/verbal clarity

Education

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

Advanced degree preferred

Tools

Quality management systems

Electronic records systems

Validation tooling

Job description

AbbVie is seeking a qualified professional to own the lifecycle management, validation, and sustained operation of digital quality systems. You will serve as the Quality subject‑matter expert for digital quality technologies, ensuring systems are compliant, inspection‑ready, and aligned with cGMP and data integrity requirements.

The role requires collaboration across Quality, Manufacturing, IT, Engineering, and Validation to define, configure, test, deploy, and sustain compliant digital