Remote-Eligible Quality Systems Architect (GxP, eQMS)

KBI Biopharma, Inc.; Boulder (CO); Hybrid; USD 140,000 - 170,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Quality Systems Software Architect to design and maintain GxP-regulated quality applications in a biopharma setting.

The role demands autonomy, architectural leadership, and deep expertise in quality systems across eQMS, deviation/CAPA, change management, audits, and document management. Responsibilities include implementing software engineering best practices, ensuring regulatory compliance (FDA/EMA/ICH), data integrity, security, and audit readiness, and

Qualifications

• Bachelor’s degree in CS, Software Engineering, Information Systems or related field; Master’s degree preferred.
• 5+ years supporting GxP-regulated systems in pharma/biotech/medical devices.

Responsibilities

• Design, develop, configure, and support enterprise Quality applications (e.g., eQMS, deviation/CAPA, change management, audits, document management).
• 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 and improve reliability.
• Lead disaster recovery planning and exercise execution, business continuity, and system lifecycle management.

Skills

GxP-regulated systems

Software engineering

Regulatory compliance

Root cause analysis

Technical leadership (influences tech)

Education

Bachelor’s degree in CS/Software Engineering/IS

Master’s degree preferred

Tools

EtQ

CSA

Job description

KBI Biopharma, Inc. is seeking a Senior Quality Systems Software Architect to design and maintain GxP-regulated quality applications in a biopharma setting.

The role demands autonomy, architectural leadership, and deep expertise in quality systems across eQMS, deviation/CAPA, change management, audits, and document management. Responsibilities include implementing software engineering best practices, ensuring regulatory compliance (FDA/EMA/ICH), data integrity, security, and audit readiness, and