高级质量系统软件架构师
Senior Quality Systems Software Architect
职位概述：
高级质量系统架构师是一个经验丰富的个人贡献者，负责在生物制药环境中设计、开发、实施和持续支持符合GxP规范的质量应用程序。
该职位具有高度的自主性，影响技术方向，并作为软件工程最佳实践的专家。
职位职责：
- 设计、开发、配置和支持企业级质量应用程序（例如，eQMS、偏差/CAPA、变更管理、审计、文档管理）。
- 实践软件工程标准、最佳实践和质量系统的架构模式。
- 为初级工程师和跨职能团队成员提供技术指导和辅导。
- 评估并推荐新方法以提高质量系统性能和合规性。
- 确保所有系统和变更符合GxP、FDA、EMA、ICH及其他全球监管要求。
- 确保质量应用程序中的数据完整性、系统安全性和审计准备。
- 将业务和质量流程需求转化为可扩展的技术解决方案。
- 为影响质量运营的系统问题提供高级故障排除和根本原因分析。
- 领导持续改进计划，减少手动流程，提高系统可靠性，并提升用户体验。
- 领导灾难恢复计划和演练执行、业务连续性以及系统生命周期管理计划。
所需知识、技能与能力
- 计算机科学、软件工程、信息系统或相关领域的学士学位（硕士优先）。
- 8–12年以上专业软件工程或应用支持经验。
- 5年以上在制药、生物技术或医疗器械行业支持GxP规范系统的经验。
- 在质量应用程序（商业或自定义eQMS平台）方面有实际经验。
- 有在无直接人员管理责任的情况下执行复杂技术项目的经历。
- 有企业应用开发和/或配置经验（例如，Python、API、SQL、数据库）。
- 对软件开发生命周期（SDLC）、受监管环境中的敏捷/DevOps实践有深入了解。
- 有计算机系统验证（CSV）方法、数据完整性原则和审计准备的经验。
期望知识、技能与能力
查看英文原文
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 planning.
Required Knowledge, Skills, & Abilities
- Bachelor’s degree in Computer Science, Software Engineering, Information Systems, or related field (Master’s degree preferred).
- 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 (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 (e.g., python, APIs, SQL, databases).
- Strong understanding of Software Development Lifecycle (SDLC), Agile/DevOps practices in a regulated environment.
- Experience in Computer System Validation (CSV) methodologies, data integrity principles, and audit readiness.
Desired Knowledge, Skills, & Abilities
- Experience with EtQ
- Experience with Computer Software Assurance (CSA)
- Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.
KBI 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.
I 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.
I 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. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
Originally posted on Himalayas