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+ yearsof professional software engineering or application support experience.
- 5+ yearssupporting 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.
