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.
The role operates with a high degree of autonomy, influences technical direction, and serves as a subject matter expert for software engineering best practices.
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 EtQ
- Experience with Computer Software Assurance (CSA)
- Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.
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.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
