Senior Quality Systems Software Architect

JSR Micro, Inc.

. Design, develop, configure, and support enterprise Quality applications such as eQMS, deviation/CAPA, change management, audits, and document management systems .

Posted 9/24/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in designing and supporting Quality applications in compliance with GxP and global regulatory standards, while applying software engineering best practices and leading continuous improvement initiatives. Proficient in translating business requirements into scalable technical solutions and providing technical guidance to cross-functional teams.

Highest-signal resume keywords

Quality Application DevelopmentGxP ComplianceSoftware Development Lifecycle (SDLC)Computer System Validation (CSV)Python Programming

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software EngineeringApplication SupportEnterprise Application DevelopmentAPIsSQLDatabasesAgile PracticesDevOps PracticesRoot Cause AnalysisDisaster Recovery Planning

Soft Skills

Technical GuidanceMentoringAutonomyInfluencing Technical DirectionCollaboration

Tools & Technologies

EQMSEtQComputer Software Assurance (CSA)Document Management SystemsChange Management Systems

Industry Keywords

FDAEMAICHData IntegrityAudit ReadinessPharmaceutical IndustryBiotech IndustryMedical Device IndustryFDA 21 CFR Part 11Annex 11

Tech Stack

Tools & technologies

PythonSDLCSQL

About the role

Key responsibilities & impact

Design, develop, configure, and support enterprise Quality applications such as eQMS, deviation/CAPA, change management, audits, and document management systems
Apply 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 approaches to improve Quality system performance and compliance
Ensure 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 disaster recovery planning and exercise execution, business continuity, and system lifecycle management planning
Operate with a high degree of autonomy, influence technical direction, and serve as a subject matter expert for software engineering best practices

Requirements

What you’ll need

Bachelor’s degree in Computer Science, Software Engineering, Information Systems, or related field
8–12+ years of professional software engineering or application support experience
5+ years supporting GxP-regulated systems within the pharmaceutical, biotech, or medical device industry
Proven experience with Quality applications, including 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, including Python, APIs, SQL, and databases
Strong understanding of Software Development Lifecycle (SDLC) and Agile/DevOps practices in a regulated environment
Experience in Computer System Validation (CSV) methodologies, data integrity principles, and audit readiness
Experience with EtQ
Experience with Computer Software Assurance (CSA)
Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations

Benefits

Comp & perks

EEO/AA employer actively seeking 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