Senior Quality Systems Architect
Job Summary
Working remotely in a full-time capacity, the Senior Quality Systems Architect will design, develop, and support GxP-regulated Quality applications while influencing technical direction and mentoring junior engineers in a biopharmaceutical environment.
Key responsibilities
- Design, develop, and configure enterprise Quality applications such as eQMS and document management systems
- Ensure compliance with GxP, FDA, EMA, and ICH regulatory requirements while maintaining data integrity and system security
- Lead continuous improvement initiatives to enhance system reliability and user experience
Required qualifications
- Bachelor's degree in Computer Science, Software Engineering, Information Systems, or a related field; Master's degree preferred
- 8-12+ years of professional software engineering or application support experience
- 5+ years of experience supporting GxP-regulated systems in the pharmaceutical, biotech, or medical device industry
- Proven experience with Quality applications and enterprise application development (e.g., Python, APIs, SQL)
- Strong understanding of Software Development Lifecycle (SDLC) and Agile/DevOps practices in a regulated environment
Complete Job Description
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