AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

AbbVie’s Quality Change Management function supports global and local internal manufacturing sites, suppliers, and Third-Party Manufacturers for Drugs, Biologics, Medical Devices, and Combination products by ensuring completeness and compliance to procedure and regulatory requirements. Analyzes and collects data for changes to product or quality system intended to support continuous improvement. Uses expertise within a specific scientific area to ensure Change Management compliance through ongoing preparation and monitoring of conformance to established Change Management procedures and processes.

• Evaluates Change Records to ensure change request is complete and compliant with AbbVie's global and local procedures and regulations before processing in the quality management system tool
• Serves as Quality approver for lower risk or no product impact changes in the quality management system tool. May consult with Product Quality team to approve Change Management records
• Collaborates with more senior members of the team to review or create change plans
• Compiles quality data, identifies data trends, and follows up with Change Management Record creator accordingly to resolve discrepancies based on those trends
• May serve as the Change Management Training point of contact on cross-functional teams, assigning relevant curriculum to users, providing needed on the job training as necessary
• Serves as a back-up for creating communications for Discontinuations and Market Expansions
• Prepares reports, queries, dashboards, and landscape reports from the quality management system tool in order to distill insights and recognize discrepancies in the change record data that require follow-up. Sets up databases as needed in the quality management system tool
• Supports cross-functional team discussions and Change Review Board meetings by preparing agendas and documenting meeting minutes.
• May manage and process Document Change Control packages within the relevant document control quality management system.
• Develops, monitors, and enforces site-wide Key Performance Indicators (KPIs) for change management by identifying relevant metrics, maintaining their accuracy, and ensuring consistent application throughout the organization.