Senior Software Quality Engineer

The Associate Business Systems Consultant supports the integration of Business Technology Solutions (BTS) Software Quality Assurance (SQA) Compliance and Technology Enablement teams in delivering solutions aligned to the Technology Solution Lifecycle (TSL). The role assists in interpreting and translating pharmaceutical regulatory requirements (GxP CSV Part 11 Annex 11) and ensuring they are embedded into technology practices and CI/CD pipelines. Supports identification of 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

• Support liaison activities between SQA Compliance and BTS technology enablement teams; help broker services facilitate stakeholder alignment and surface interdependencies for resolution. 
• Assist in analyzing business strategies processes and regulatory drivers to identify opportunities for improving quality compliance and process efficiency enabled by technology.  
• Support the interpretation and translation of compliance and business requirements (GxP CSV Part 11 Annex 11 SLC) into user stories acceptance criteria functional requirements and process updates.  
• Contribute to the development maintenance and validation of traceability matrices linking requirements controls system design elements and verification evidence; ensure documentation is accurate and inspection-ready. 
• Collaborate with development DevOps and automation teams to support embedding compliant quality controls into TSL tools including requirements/design management testing CI/CD workflows deployment and monitoring. 
• Assist cross-functional teams in implementing improvement programs including shift-left testing risk-based validation automation and process simplification. 
• Support compliance with Corporate and Divisional policies standards and governance; assist in evaluating solution alternatives using standard IS methodologies and identifying regulatory impacts.  
• Coordinate with BTOs and BTS teams to support integration efforts maintain cross-functional relationships and ensure effective engagement and communication.  
• Participate in delivering training and awareness activities on compliant quality engineering practices requirements and regulatory updates.  
• Assist with audit and inspection readiness activities; support document preparation evidence collection and remediation. 

Qualifications :

• Bachelors Degree with 6 years experience; Masters Degree with 5 years experience; PhD with 0 years experience.

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 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 Companys sole and absolute discretion unless and until paid 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. 

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Work :

No

Employment Type :

Full-time