Systems Quality Engineer

AbbVie Inc.; Tempe (AZ); In loco; USD 66.000 - 126.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid time off

Medical/dental/vision insurance

401(k)

Short-term incentive programs

Descrizione del lavoro

AbbVie in Tempe seeks a Quality Systems Lead to own the lifecycle management, validation, and ongoing operation of digital quality systems, ensuring cGMP compliance and data integrity.

You will translate business and compliance requirements into system specifications, collaborate with Quality, Manufacturing, IT, Engineering, and Validation, and drive continuous improvement while maintaining inspection readiness.

Competenze

• Bachelor’s degree in engineering, computer science, life sciences, or a related technical discipline.
• 5+ years of relevant experience in regulated manufacturing environments.
• Experience with quality management systems and electronic records systems.
• Strong written and verbal communication skills; ability to work independently.
• Ability to influence stakeholders without direct authority.

Mansioni

• Lead Quality ownership of digital quality systems, including implementation, enhancement, lifecycle management, and operational support for quality-related capabilities.
• Act as the Quality system SME, translating requirements into system specifications and controls.
• Partner with Quality, Manufacturing, IT, Engineering, Validation, and others to define, test, deploy, and sustain compliant digital solutions.
• Own or coordinate Quality input to software validation activities, including risk assessments, tests, traceability, and validation deliverables.
• Ensure electronic data integrity and records throughout the data lifecycle.
• Lead change-control processes and periodic assessments for system changes.
• Support investigations of deviations, incidents, data-integrity events, and CAPAs.
• Develop procedures, work instructions, training materials to promote compliant use.
• Monitor system performance and drive continuous improvements with stakeholders.
• Maintain inspection readiness and respond to audits and regulatory inquiries.

Conoscenze

Communication skills

Independent work

Influence stakeholders

Attention to detail

Formazione

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

Advanced degree preferred

Strumenti

Quality management systems

Electronic records systems

Computer system validation tools

Descrizione del lavoro

• Compensation: USD 65,500 - USD 125,500 - yearly

Company Description

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.

Job Description

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.

Qualifications

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.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion consistent withapplicable 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.