Description

You will lead the Quality Control Technical Services Data Integrity function, ensuring QC laboratory systems, instruments, software, and data workflows meet regulatory expectations for data integrity and GxP compliance. You'll partner with QC operations, Validation, IT, and system owners to design and maintain compliant systems.

Requirements

• Experience with data integrity and GxP compliance in a QC laboratory environment
• Knowledge of computerized system validation and instrument qualification
• Ability to collaborate cross-functionally with QC, Validation, IT, and system owners

Responsibilities

• Ensure QC laboratory systems, instruments, software, and data workflows meet regulatory expectations for data integrity and GxP compliance
• Provide expert oversight and support for computerized system implementation, instrument qualification, assay data workflows, software validation, and data governance
• Partner closely with QC operations, Validation, IT, and system owners