{"id":2607412,"url":"https://alion.io/job/kbi-biopharma-senior-quality-systems-software-architect","title":"Senior Quality Systems Software Architect","company":{"id":2599767,"name":"KBI Biopharma","domain":"kbibiopharma.com","url":"https://alion.io/company/kbibiopharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":7,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":35,"computed_at":"2026-11-02T06:13:15Z"}},"role":"Backend","role_family":"Backend","seniority":"staff","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":143000,"max_usd":244000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":512},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"Python","optional":false},{"name":"SQL","optional":false}],"status":"live","first_seen_at":"2026-09-24T00:00:00Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-11-02T08:44:10Z","board_verified":true,"closed_at":null,"days_open":39,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":39},"description":"Job Summary:\nThe 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.\nThe role operates with a high degree of autonomy, influences technical direction, and serves as a subject matter expert for software engineering best practices.\nJob Responsibilities:\nDesign, develop, configure, and support enterprise Quality applications (e.g., eQMS, deviation/CAPA, change management, audits, document management).\nPractice software engineering standards, best practices, and architectural patterns for Quality systems.\nProvide technical guidance and mentoring to junior engineers and cross-functional team members.\nEvaluate and recommend new approaches to improve Quality system performance and compliance.\nEnsure all systems and changes comply with GxP, FDA, EMA, ICH, and other global regulatory requirements.\nEnsure data integrity, system security, and audit readiness across Quality applications.\nTranslate business and quality process requirements into scalable technical solutions.\nProvide advanced troubleshooting and root cause analysis for system issues impacting Quality operations.\nLead continuous improvement initiatives to reduce manual processes, improve system reliability, and enhance user experience.\nLead to disaster recovery planning and exercise execution, business continuity, and system lifecycle management planning.\nRequired Knowledge, Skills, & Abilities\nBachelor’s degree in Computer Science, Software Engineering, Information Systems, or related field (Master’s degree preferred).\n8-12+ years of professional software engineering or application support experience.\n5+ years supporting GxP-regulated systems within the pharmaceutical, biotech, or medical device industry.\nProven experience with Quality applications (commercial or custom-built eQMS platforms).\nDemonstrated experience executing complex technical initiatives without direct people management responsibility.\nExperience with enterprise application development and/or configuration (e.g., python, APIs, SQL, databases).\nStrong understanding of Software Development Lifecycle (SDLC), Agile/DevOps practices in a regulated environment.\nExperience in Computer System Validation (CSV) methodologies, data integrity principles, and audit readiness.\nDesired Knowledge, Skills, & Abilities\nExperience with EtQ\nExperience with Computer Software Assurance (CSA)\nFamiliarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.\nKBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.\nI understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.\nI attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. 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