Senior Quality Systems Architect (GxP eQMS & Compliance)

KBI Biopharma, Inc.; Raleigh (NC); On-site; USD 140,000 - 180,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Quality Systems Architect to design, develop, and support GxP-regulated quality applications in a biopharma setting. This role focuses on implementing eQMS, deviation/CAPA, change management, audits, and document management within a compliant architecture.

The successful candidate will lead technical initiatives, guide junior engineers, and ensure data integrity, security, and audit readiness across systems while aligning to global regulatory requirements.

Qualifications

• Must have 5+ years supporting GxP-regulated systems in pharma/biotech.
• Experience implementing eQMS and regulatory-compliant applications.
• Strong SDLC knowledge and validated computer systems experience.
• Ability to translate process requirements into scalable technical solutions.

Responsibilities

• Design, develop, configure, and support enterprise Quality apps (eQMS, CAPA, change management, audits, docs).
• Apply SDLC/architecture patterns and software engineering best practices for Quality systems.
• Provide technical guidance to junior engineers and cross-functional teams.
• Evaluate new approaches to improve Quality system performance and compliance.
• Ensure systems comply with GxP, FDA, EMA, ICH, and global requirements.
• Lead disaster recovery planning, business continuity, and lifecycle management.
• Drive continuous improvement to reduce manual processes and improve UX.

Skills

GxP-regulated systems experience

Quality applications (eQMS, deviation/

SDLC, Agile/DevOps in regulated env

Troubleshooting & root cause analysis

Leadership without direct people mgmt

Education

Bachelor's degree in Computer Science/Software Engineering/Information Systems

Master's degree preferred

Tools

Python

APIs

SQL

Databases

Job description

KBI Biopharma, Inc. is seeking a Senior Quality Systems Architect to design, develop, and support GxP-regulated quality applications in a biopharma setting. This role focuses on implementing eQMS, deviation/CAPA, change management, audits, and document management within a compliant architecture.

The successful candidate will lead technical initiatives, guide junior engineers, and ensure data integrity, security, and audit readiness across systems while aligning to global regulatory requirements.