Senior GxP Quality Systems Architect

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

Job summary

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

This individual contributor role operates with autonomy and serves as a SME for software engineering best practices. Responsibilities include building and maintaining eQMS, deviation/CAPA, change management, audits, and document management; ensuring data integrity, security, and regulatory alignment; and leading initiatives to improve

Qualifications

• Bachelor's degree in a related field; Master’s preferred.
• 8-12+ years in software engineering or application support.
• >=5 years supporting GxP-regulated systems in pharma/biotech/medical devices.
• Proven experience with Quality applications (commercial or custom-built eQMS).
• Experience executing complex technical initiatives without people management.
• Experience with enterprise app development/configuration (Python, APIs, SQL).
• Strong SDLC and Agile/DevOps in a regulated environment.

Responsibilities

• Design, develop, configure, and support enterprise Quality applications (eQMS, deviation/CAPA, change management, audits, document management).
• Apply software engineering standards and architectural patterns for Quality systems.
• Provide technical guidance and mentoring 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.
• Maintain data integrity, security, and audit readiness across Quality apps.
• Translate business requirements into scalable technical solutions.
• Lead root cause analyses and continuous improvement initiatives.
• Lead disaster recovery planning, business continuity, and lifecycle management.

Skills

Software engineering

GxP compliance

SDLC & Agile/DevOps

Python & APIs

SQL & Databases

CSV validation

Leadership without management

Education

Bachelor's in Computer Science/Software Engineering/IS

Master's degree preferred

Tools

eQMS platforms

EtQ

CSA (Computer Software Assurance)

Job description

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

This individual contributor role operates with autonomy and serves as a SME for software engineering best practices. Responsibilities include building and maintaining eQMS, deviation/CAPA, change management, audits, and document management; ensuring data integrity, security, and regulatory alignment; and leading initiatives to improve