Senior Quality Systems Software Architect

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

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.

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 EtQExperience with Computer Software Assurance (CSA)Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.

EEO/AA Commitment

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.