Director, Clinical Quality Assurance

Role: The Director of Clinical Quality Assurance (QA) at AbbVie leads global strategic quality oversight within clinical development, ensuring compliance with regulations and embedding quality in clinical trial processes across Therapeutic Areas (TAs). Objectives include advancing clinical programs, ensuring inspection readiness, and supporting regulatory submissions. Responsibilities encompass developing and executing quality strategies, building high-performing TA-specific teams, collaborating with vendor and internal QA units, and guiding health authority inspections. The role demands proactive quality management, process improvement, and risk mitigation aligned with GxP standards, especially GCP. Qualifications required include a Bachelor’s degree in science or related field, 12+ years’ biopharma experience with at least 5 years in leadership roles, extensive knowledge of global regulatory requirements, and expertise in clinical development, compliance, and quality systems. Preferred skills include strong analytical, leadership, negotiation, and communication abilities, along with proven experience in managing complex projects and cross-functional teams. The position involves significant international travel (10-20%) and can be based in IL, CA, EU, or UK. High-value specifics include focus on biopharmaceuticals in clinical phases, GCP compliance, and regulatory interactions, emphasizing quality excellence in the development pipeline.