All jobs → Partner boards

Senior Quality Systems Software Architect

KBI Biopharma • NC, US • published 2026-09-25 15:51:32.275070

Description

**Job Summary:** The Senior Quality Systems Architect is a highly experienced individual contributor responsible for the design, development, implementation, and ongoing support of GxP\-regulated Quality applications within a biopharmaceutical environment. The role operates with a high degree of autonomy, influences technical direction, and serves as a subject matter expert for software engineering best practices. **Job Responsibilities:** * Design, develop, configure, and support enterprise Quality applications (e.g., eQMS, deviation/CAPA, change management, audits, document management). * Practice software engineering standards, best practices, and architectural patterns for Quality systems. * Provide technical guidance and mentoring to junior engineers and cross\-functional team members. * Evaluate and recommend new approaches to improve Quality system performance and compliance. * Ensure all systems and changes comply with GxP, FDA, EMA, ICH, and other global regulatory requirements. * Ensure data integrity, system security, and audit readiness across Quality applications. * Translate business and quality process requirements into scalable technical solutions. * Provide advance...

Get jobs like this daily in Telegram: @careeri_bot