New · posted Oct 21
AbbVie · Pharmaceuticals
Digital Quality Engineer
- Tempe, AZ
- On-site
- Full-time
- Senior & Principal
Open until filled
What you need
What you'll do
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 employee 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Pay and benefits
$66,000 – $126,000 a year
Employer providedPaid time off
Medical insurance
Dental insurance
Vision insurance
401(k)
Short-term incentive programs
Where you'll work
Tempe, AZOn-siteOpen in Maps (opens in a new tab)
More jobs in Tempe, AZ
From the posting
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.
Equal opportunity, accessibility and legal noticesAbbVie's statements, word for word
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 applicants seeking a reasonable accommodation, click here to learn more:
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 19% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Arizona8 roles publishing pay
Senior & Principal roles in the US313 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $66,000 | — | $126,000 |
| Arizona (middle half) | $109,375 | $116,500 | $120,250 |
| All US (middle half) | $102,500 | $119,000 | $137,500 |
This role: AbbVie's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not AbbVie's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems7
- Collaboration and leadership7
- GMP and compliance6
- Documentation and SOPs6
- Quality systems and risk6
- Validation and qualification5
- Lab testing and methods4
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
AbbVie on Regulatory Jobs
- 51
- Open roles
- 31
- Distinct roles
- 11
- Locations
By discipline
- Regulatory28 55%
- Quality22 43%
- Compliance & Safety1 2%
By level
- Director22 43%
- Manager15 29%
- Senior & Principal9 18%
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Digital Quality Engineer at AbbVie
Open until filled. $66K–$126K a year, employer provided.