Senior Quality Systems Software Architect

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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. 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

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