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Senior GMP Applications Administrator

Partner Therapeutics
United StatesremoteEnglish120k-145k USD/year2d ago
operations

POSITION SUMMARY The Senior GMP Applications Administrator serves as a key technical partner supporting the reliable and compliant use of critical business and laboratory systems within a regulated biopharmaceutical manufacturing environment. This role combines strong application and database expertise with an understanding of cGMP operations, data integrity, and computerized system requirements. Working across IT, Quality, Manufacturing, Engineering, Validation, and external partners, the position helps ensure technology solutions effectively support business needs, regulatory expectations, and ongoing operational improvement. PRIMARY RESPONSIBILITIES Administers, maintains, supports, and optimizes enterprise and laboratory applications, including Maximo, NuGenesis, MODA, and Empower. Serves as a technical subject matter expert and primary IT resource for assigned applications. Monitors application performance, availability, integrations, system health, and proactively address potential issues. Supports requests for enhancements, reports, configuration changes, patches, data migrations, and system implementations. Troubleshoots application, database, interface, configuration, and user-access issues in partnership with internal teams and external vendors. Plans and executes system upgrades while minimizing operational disruption and maintaining validated system status. Supports database administration activities, including queries, troubleshooting, system interfaces, backups, and data integrity. Ensures the integrity, security, availability, and appropriate access control of regulated application data. Partners with Quality and Validation teams to support computer system validation and lifecycle management activities. Develops, revises, reviews, and maintains application-related SOPs, work instructions, system documentation, configuration documentation, and technical procedures. Participates in change controls and other quality-system activities associated with computerized systems. Ensures assigned systems are maintained in accordance with cGMP, data-integrity principles, company policies, and applicable regulatory requirements. Collaborates with laboratory, manufacturing, engineering, quality, and business users to understand system requirements and recommend technical solutions. Coordinates with software vendors and service providers to resolve issues, implement enhancements, and support application lifecycle activities. Leads or supports IT projects...

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