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Job Description
Legend Biotech is seeking an Associate Director, Site IT and Manufacturing Systems Lead to set the direction of manufacturing IT systems supporting clinical and commercial manufacturing. This role ensures the quality and efficiency of IT projects and deployments. The Associate Director will also drive solutions to Enterprise IT System-related demands, including building, testing, documenting, and implementing design changes.Role involves:- Managing the implementation of new and existing Manufacturing IT systems.
- Supporting review of change controls associated with manufacturing systems.
- Executing and documenting change control.
- Testing changes/enhancements and setting up validation testing.
- Collaborating with manufacturing and IT teams.
- Improving compliance and the efficiency of manufacturing operations.
- Authoring and revising procedural documents.
- Training users and providing ad hoc support.
- Communicating technical issues and activity status updates.
- Processing user account requests and maintaining up-to-date knowledge.
- Providing support for internal compliance and regulatory agency inspections.
- Minimum B.S. degree in a relevant scientific, computer, or engineering program.
- At least 10 years’ experience.
- Experience developing and deploying an Enterprise Manufacturing Execution System (MES).
- Knowledge of biopharmaceutical or cell therapy manufacturing.
- Proficient knowledge of system interfaces (CMMS, LIMS, ERP, document management system).
- Proficient knowledge of Microsoft Office Applications.
- Ability to work independently and troubleshoot issues.
- Knowledge of software development lifecycle (SDLC) and computer systems validation (CSV).
- Strong interpersonal, oral, and written communication skills.
- Opportunity to work in a team-based, collaborative, and positive environment.
- Chance to contribute to business process improvements and operational excellence.
- Involvement in multiple complex projects.
