Senior Manager, Software Quality Engineering
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Leads the strategic integration of Software Quality Assurance (SQA) Compliance and BTS Technology Enablement teams delivering the Technology Solution Lifecycle (TSL) automation tools. Responsible for ensuring pharmaceutical regulatory requirements (GxP CSV Part 11 Annex 11) are accurately interpreted translated and embedded into technology practices and CI/CD pipelines. Accountable for identifying strategic business opportunities shaping compliant technology solutions leading process modernization and ensuring alignment of digital quality engineering with business and regulatory expectations across multiple business areas.
Responsibilities
- Lead as the primary liaison between SQA and Compliance leaders and BTS technology enablement teams; broker services align stakeholders and resolve interdependencies across multiple business areas.
- Responsible for analyzing business strategies processes and regulatory drivers across business units to identify needs and opportunities for quality and compliance improvement enabled by technology.
- Accountable for interpreting and translating compliance and quality requirements (GxP CSV Part 11 Annex 11 SLC) into epics user stories acceptance criteria functional specifications and process changes.
- Lead development maintenance and validation of traceability matrices linking requirements controls system design and verification evidence; ensure inspection-ready documentation.
- Partner with development DevOps and automation teams to embed compliant quality controls into TSL tools including risk profiling requirements/design management CI/CD testing deployment and monitoring.
- Lead significant cross-functional improvement programs including shift-left testing risk-based validation automation and process simplification.
- Responsible for ensuring compliance with Corporate and Divisional policies standards and governance; evaluate solution alternatives using standard IS methodologies and assess regulatory impacts.
- Lead integration efforts with BTOs/BTS teams maintain strong cross-functional relationships broker services manage interdependencies and support customer engagement.
- Lead a significant area of work with technical financial and quality accountability; establish objectives delegate assignments develop talent and deliver training and awareness on compliant quality engineering and regulatory changes.
Qualifications :
Required:
- Bachelors Degree with 8 years experience; Masters Degree with 7 years experience; PhD with 3 years experience.
- Exercises latitude in the approach to problem solving.
- Work checked through consultation and agreement with others rather than formal review by superiors.
- Familiarity with key regulatory domains (GxP SOX PCI Privacy Toxins Security Cybersecurity NIS2 AI Accessibility etc).
- Experience with controls frameworks
Preferred:
- Experience working across multiple business areas within BTS/BTO.
- Experience supporting audits/inspections and leading CAPA remediation.
- Experience driving automation compliance modernization or validation transformation programs.
Additional Information :
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 postingbased 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 paymore 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 commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and untilpaid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Data Center Experience
- ArcGIS
- Cloud Infrastructure
- Construction Estimating
- Go
- Mathcad
- React
- Redux
- AWS
- Software Development
- Auto Estimating
- Distributed Systems
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
