System Administrator, Documentation & Training GQA
$92.16k - $138.24kDaiichi Sankyo US
Job Summary The System Administrator, Documentation and Training GQA is responsible for the day-to-day administration, configuration, and support of the company's regulated electronic document management system (EDMS) and learning management systems (LMS). This role ensures that GxP controlled documents and training records are managed in compliance with global regulatory requirements and internal quality standards. The System Administrator partners closely with Quality, Regulatory, IT/DX, and business stakeholders across the globe to support document lifecycle management, role-based training deployment, user access control, and system enhancements. Acting as a key operational owner, the role supports system validation activities, change management, and continuous improvement initiatives to ensure the reliability, integrity, and effective use of the EDMS and LMS throughout the organization. Responsibilities Administer and support the electronic document management system (EDMS), including document lifecycle workflows, metadata configuration, document types, and user access controls, to ensure compliant management of GxP controlled documentation. Administer and support the learning management systems (LMS), including creation and maintenance of training items, curricula, user groups, and role-based training assignments, ensuring accurate training records and compliance with internal requirements. Monitor system performance ensuring the reliability, availability, and accuracy of document and training records used to demonstrate regulatory compliance. Serve as a primary point of contact for users, providing day-to-day support, troubleshooting, and guidance related to EDMS and LMS access, functionality, and usage. Collaborate with Quality, Regulatory, Training, IT/DX, and business stakeholders in global regions to support document and training processes and address system-related issues or improvement opportunities. Support communication and coordination across global time zones, including participation in international meetings as required. Support compliance monitoring activities by tracking training completion and overdue training, escalating issues as needed to ensure adherence to internal standards and regulatory expectations. Participate in system enhancements, upgrades, configuration changes, and validation testing activities for both the EDMS and LMS, in collaboration with IT/DX and Quality teams. Qualifications Must have an Associate's Degree or higher. 4 or more years of professional pharmaceutical industry experience managing GxP document management and training activities in the pharmaceutical or biotech industry, or equivalent experience. Experience working in Veeva Quality Docs & ComplianceWire (highly preferred) and with GxP principles. Strong software and computer skills, proficient in MS Office applications, including Teams and Excel. Knowledge of UAT or Validation experience. Proactive and positive approach to providing solutions. Ability to operate independently and make informed decisions. Ability to work with cross-functional teams within a global matrixed environment. Availability to participate in early morning or late evening global calls. Travel Requirements Ability to travel up to 5% of the time domestic and international. Salary Range
USD$92,160.00 - USD$138,240.00
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. #J-18808-Ljbffr Daiichi Sankyo US$92.16k - $138.24k
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