Senior Quality Systems Software Architect
KBI Biopharma5 days ago
Remote, United StatesSenior
Responsibilities
- Design, develop, configure, and support enterprise Quality applications such as eQMS, deviation/CAPA, change management, audit, and document management systems.
- Apply software engineering standards, best practices, and architectural patterns to Quality systems.
- Provide technical guidance and mentoring to junior engineers and cross-functional team members.
- Translate business and quality-process requirements into scalable technical solutions.
- Ensure systems and changes comply with GxP, FDA, EMA, ICH, and other global regulatory requirements.
- Maintain data integrity, system security, and audit readiness across Quality applications.
- Perform advanced troubleshooting and root-cause analysis for issues affecting Quality operations.
- Lead continuous-improvement initiatives that reduce manual work, improve system reliability, and enhance user experience.
- Lead disaster-recovery planning and exercises, business-continuity activities, and system-lifecycle planning.
Requirements
- Bachelor’s degree in Computer Science, Software Engineering, Information Systems, or a related field is required; a master’s degree is preferred.
- 8–12+ years of professional software engineering or application-support experience.
- At least 5 years supporting GxP-regulated systems in the pharmaceutical, biotech, or medical-device industry.
- Proven experience with commercial or custom-built eQMS platforms and Quality applications.
- Experience executing complex technical initiatives without direct people-management responsibility.
- Experience with enterprise application development or configuration, including Python, APIs, SQL, and databases.
- Understanding of software development lifecycle practices and Agile/DevOps practices in regulated environments.
- Experience with Computer System Validation methodologies, data-integrity principles, and audit readiness.
- Experience with EtQ is desired.
- Experience with Computer Software Assurance and familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations are desired.
About KBI Biopharma
KBI Biopharma is a contract development and manufacturing organization (CDMO) that provides analytical characterization, process development, and cGMP manufacturing for biologics to pharmaceutical and biotechnology companies. Its services span cell line development, fermentation and cell culture, downstream purification, formulation, and release/stability testing for microbial and mammalian programs. Founded in 1996 and headquartered in Durham, North Carolina, it operates as part of JSR Life Sciences.