About the job
Purpose:
At AbbVie, we are committed to advancing healthcare by providing innovative, safe, and effective medicines that address significant health challenges and enhance the quality of life for patients. Our R&D Quality Assurance (RDQA) team plays a critical role in ensuring quality excellence throughout the product lifecycle—from discovery to development. In an environment characterized by rapidly evolving patient needs, regulatory landscapes, and stakeholder demands, our focus on quality in clinical trials safeguards data integrity and strengthens regulatory compliance, thereby driving the success of our drug and device development initiatives.
The Director of Clinical Quality Assurance will spearhead the development and execution of global quality oversight strategies for various Therapeutic Areas (TAs) within clinical development programs. This key role ensures compliance with corporate policies and international regulations, while providing strategic leadership to guarantee inspection readiness and comprehensive QA insights. By influencing decision-making processes, this role integrates quality requirements into improvement initiatives, supporting global Clinical Development efforts. The Director will focus on achieving quality excellence, maintaining data integrity, and facilitating the successful submission of new therapies in alignment with AbbVie’s quality systems, including CAPA, Change Management, Quality Risk Management, and Documentation Standards. The scope of this role encompasses R&D and clinical research activities aimed at advancing our pipeline and achieving first-pass approvals. This position reports directly to the Senior Director of Clinical Quality Assurance.
This role may be based in AbbVie’s locations in Lake County, IL; Irvine, CA; or the EU/UK.

