Senior Quality Systems Software Architect

KBI Biopharma, Inc.; North Carolina; Hybrid; USD 140,000 - 180,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Senior Quality Systems Architect to design, implement, and support GxP-regulated quality applications in a biopharma setting.

You will influence technical direction, serve as a SME for software engineering practices, and mentor junior engineers across cross-functional teams. The role requires deep knowledge of quality systems, GxP compliance, and modern SDLC/DevOps in regulated environments.

Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Information Systems, or related field.
• 8–12+ years of professional software engineering or application support experience.
• 5+ years supporting GxP-regulated systems within pharma/biotech/medical device industry.
• Proven experience with Quality applications (eQMS platforms).
• 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 SDLC, Agile/DevOps practices in a regulated environment.
• Experience in Computer System Validation (CSV) methodologies, data integrity, and audit readiness.

Responsibilities

• Design, implement, and support enterprise Quality applications (eQMS, deviation/CAPA, change management, audits, document management).
• Apply 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 disaster recovery planning and exercise execution, business continuity, and system lifecycle management planning.

Job 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 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.

EEO Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

Company Culture

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.