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IT Quality Support is supporting Lilly China IT team to comply with corporate IT Quality Standards.
This role maintains the operations of the quality management systems, and works with project teams on quality tasks
and making quality decisions. The role provides consulting and interpretation of Lilly Computer Systems Standards by
defining risk-based validation approach, providing consultation, and reviewing deliverables.
Key Activities:
IT Quality Management System Operations:
? Assist to drive IT compliance culture and improve compliance readiness
? Operate Lilly China IT quality management system
o CAPA management
o Periodic reviews / Access reviews
o Personnel Qualification
o IT privacy
o Change Control Board
? Participate as subject matter expert in self-inspections, audits, and supplier assessments
? Assist to quality training to China IT team
Project Delivery and Support
? Assist the quality classification of a new system
? Support risk-based validation approach
? Review validation deliverables and author key deliverables
? Participate in project gate reviews
? Provide computer system validation consulting and interpretation
? Train suppliers on IT Quality Management System and quality expectations
? Escalate computer system quality issues to the appropriate persons
Requirements:
? Proficiency with IT systems development life cycle
? Experience in authoring and reviewing validation/qualification documents and associated deliverables.
? Knowledge of and expertise in IT assurance, risk assessment and business impact analysis
? Experience with problem management and tracking systems including documentation environments.
? Demonstrated strong oral and written communication, and ability to influence and collaborate
? Demonstrated ability to work independently, but also teamwork capabilities
? Written and spoken fluency in Chinese and English essential
? Bachelor (4 yr College) degree in a technology-related field or equivalent experience
? Additional education / certification in information quality management system processes would be beneficial