Senior Quality Systems Software Architect
# Senior Quality Systems Software Architect **KBI Biopharma** · United States · `Remote` · `Full Time` 💼 **Уровень роли:** `Senior` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Himalayas (JSON API)* --- ### Top Skills & Match 🎯 **Ключевой стек роли:** `[Quality-Assurance-Architect]` `[Software-Architect]` `[Quality-Systems-Engineer]` `[GxP-Systems-Engineer]` `[Quality-Assurance-Engineer]` `[Senior-Software-Architect-Reliability-Engineering]` `[Senior-Systems-Architect]` `[Senior-Systems-Software-Engineer]` `[Software-System-Architect]` --- ### About the Role 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 advanced troubleshooting and root cause analysis for system issues impacting Quality operations. - Lead continuous improvement initiatives to reduce manual processes, improve system reliability, and enhance user experience. - Lead to disaster recovery planning and exercise execution, business continuity, and system lifecycle management planning. Required Knowledge, Skills, & Abilities - Bachelor’s degree in Computer Science, Software Engineering, Information Systems, or related field (Master’s degree preferred). - 8–12+ years of professional software engineering or application support experience. - 5+ years supporting GxP-regulated systems within the pharmaceutical, biotech, or medical device industry. - Proven experience with Quality applications (commercial or custom-built eQMS platforms). - Demonstrated experience executing complex technical initiatives without direct people management responsibility. - Experience with enterprise application development and/or configuration (e.g., python, APIs, SQL, databases). - Strong understanding of Software Development Lifecycle (SDLC), Agile/DevOps practices in a regulated environment. - Experience in Computer System Validation (CSV) methodologies, data integrity principles, and audit readiness. Desired Knowledge, Skills, & Abilities - Experience with EtQ - Experience with Computer Software Assurance (CSA) - Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma , Inc. to hire me. If I am hired, I understand that either KBI Biopharma , Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma , Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma , Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma , Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal. Originally posted on Himalayas
- Quality-Assurance-Architect
- Software-Architect
- Quality-Systems-Engineer
- GxP-Systems-Engineer
- Quality-Assurance-Engineer
- Senior-Software-Architect-Reliability-Engineering
- Senior-Systems-Architect
- Senior-Systems-Software-Engineer
- Software-System-Architect
Наблюдалась 2026-09-28, впервые 2026-09-28, источник — Himalayas (JSON API).