Senior Quality Systems Architect - GxP & eQMS Expert

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

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.