QA Systems Manager

The QA Manager, Systems & Process Excellence is responsible for supporting and maintaining validated GxP computerized systems, Computer System Validation (CSV), and Data Integrity (DI) programs. This role partners with Quality, Business, and System Owners to ensure system compliance, drive process improvements, support Quality Management System (QMS) activities, and maintain validated applications in accordance with regulatory requirements. Responsibilities Support the administration, validation, and continuous improvement of GxP computerized systems and Data Integrity programs. Evaluate user enhancement requests and develop solutions that improve business processes, system performance, and compliance. Gather user and functional requirements and support system implementations, configurations, and upgrades. Execute User Acceptance Testing (UAT), Performance Qualification (PQ), validation testing, and review validation documentation (URS, FS, IQ/OQ/PQ, validation plans, and reports). Manage system access, permissions, documentation, and end-user support. Perform QMS activities, including change controls, deviations, CAPAs, and documentation management. Create reports, analyze metrics, monitor system performance, and ensure data quality and regulatory compliance. Identify, assess, and resolve compliance risks while supporting continuous process improvement initiatives. Author and review CSV, DI, and QMS documentation, including policies, procedures, and lifecycle records. Support internal and external audits, inspections, and regulatory compliance activities. Qualifications Bachelor's degree in Science, Engineering, Information Technology, or a related field, or equivalent combination of education and experience. Minimum of 7 years of relevant experience, including at least 5 years supporting validated GxP computerized systems in a pharmaceutical or regulated environment. Hands-on experience with Computer System Validation (CSV), Data Integrity (DI), and maintaining validated systems. Experience with Quality Management Systems (QMS), Veeva Vault (Quality QMS/QDocs), SaaS applications, Learning Management Systems, or other regulated platforms. Strong understanding of GxP regulations, quality systems, and regulatory requirements. Experience with system administration, validation documentation, change control, deviations, CAPAs, and audit support. Knowledge of databases, computer networking, and business process improvement methodologies is preferred. #J-18808-Ljbffr Meet Life Sciences