Digital Quality Engineer

Regulatory Jobs; Tempe (AZ); Presencial; USD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits package

Short-term incentive programs

Paid time off

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

Quality systems expertise

Data integrity

Regulatory compliance

Educación

Bachelor's degree in engineering or related field

Herramientas

Software validation

Descripción del empleo

About AbbVie

AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Own the lifecycle management, validation, and sustained operation of digital quality systems and related capabilities. Serve as the Quality subject-matter expert and system owner for digital quality technologies, ensuring solutions are compliant, fit for purpose, inspection-ready, and aligned with cGMP, data integrity, and electronic records/electronic signatures requirements.

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.

• Bachelor’s degree in engineering, computer science, life sciences, or a related technical discipline; advanced degree preferred.
• 5+ years of relevant experience in pharmaceutical, biotechnology, or other regulated manufacturing environments, including Quality, Manufacturing, digital systems, or validation.
• Experience with quality management systems, electronic records systems, manufacturing or laboratory systems, or comparable GxP digital platforms strongly preferred.
• Experience with software or computer system validation, including risk-based validation, requirements, testing, traceability, and validation documentation, preferred; ability to be accountable for validation activities as needed.
• Excellent written and verbal communication skills, with the ability to develop clear procedures, training, and inspection-ready documentation.
• Ability to work independently, prioritize effectively in a dynamic project environment, and influence stakeholders without direct authority.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html