Senior Quality Systems Software Architect

This is a fully remote position, open to applicants in Colorado, +1 more state.

📋 Description

• Design, develop, configure, and provide support for enterprise Quality applications including eQMS, deviation/CAPA, change management, audits, and document management systems.

• Implement software engineering standards, best practices, and architectural patterns for Quality systems.

• Offer technical guidance and mentorship to junior engineers and cross-functional team members.

• Assess and suggest methods to enhance the performance and compliance of Quality systems.

• Ensure that systems and modifications adhere to GxP, FDA, EMA, ICH, and other global regulatory standards.

• Maintain data integrity, system security, and audit readiness across Quality applications.

• Convert business and quality process requirements into scalable technical solutions.

• Provide expert troubleshooting and root cause analysis for system issues that affect Quality operations.

• Drive continuous improvement efforts to minimize manual processes, enhance system reliability, and improve user experience.

• Oversee disaster recovery planning and execution, business continuity, and system lifecycle management planning.

• Work with a high level of autonomy, influence technical direction, and act as a subject matter expert on software engineering best practices.

⛳️ Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Information Systems, or a related discipline.

• 8–12+ years of professional experience in software engineering or application support.

• 5+ years of experience in supporting GxP-regulated systems within the pharmaceutical, biotech, or medical device sectors.

• Proven experience with Quality applications, including both commercial and custom-built eQMS platforms.

• Demonstrated ability to execute complex technical initiatives without direct management responsibilities.

• Proficient in enterprise application development and/or configuration, including Python, APIs, SQL, and databases.

• Strong comprehension of the Software Development Lifecycle (SDLC) and Agile/DevOps methodologies in a regulated context.

• Experience in Computer System Validation (CSV) practices, data integrity principles, and audit readiness.

• Familiarity with EtQ.

• Knowledge of Computer Software Assurance (CSA).

• Understanding of FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.

🏝️ Benefits

• EEO/AA employer actively working to diversify its workforce.

• Equal employment opportunity protections regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status.

• At-will employment arrangement.