Data Integrity Inspection Readiness Lead

Company Description

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

The Data Integrity Inspection Readiness Lead uses advanced subject matter expertise of global quality   standards, cGMP, and external agency regulations to lead preparedness for regulatory inspections and audits at AbbVie sites across the global network. Drives the development and maintenance of a quality culture by closely collaborating with AbbVie Manufacturing Site leadership, Quality Lab leadership, global functional groups, and Third Party Manufacturers to conduct mock audits, coach site leadership on opportunities identified, maintain roles and responsibilities, identify potential project gaps, and obtain an in-depth understanding of the quality, compliance, and resource needs at each site. Responsible for effectively providing guidance on quality concerns and preparing all global sites in the areas of small molecule pharmaceuticals, biologics, combination products, medical devices, tissue, and cosmetics for future inspections and audits.

•Focusing on data integrity, leads preparedness for regulatory inspections by ensuring AbbVie sites are compliant with global standards and regulations, conducting mock audits, and coaching site leadership on how to address opportunities identified.

•Coaches site leadership and employees during external regulatory inspections and audits to empower successful data integrity audit outcomes.

•Develops and executes data integrity campaigns, gap assessments, inspection readiness plans, audit observations and responses, and ensures corrective actions are appropriate.

•Provides consultation, guidance, and strategic input to site and global leadership teams on initiatives that enable them to set priorities, advance quality culture, and maintain sites in an inspection-