Director, Clinical Quality Assurance

Company Description

Abb Vie’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 key therapeutic areas including immunology, oncology, neuroscience, and eye care, and through our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit

Abb Vie is dedicated to delivering a consistent stream of innovative, safe, and effective medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development to accelerate access to innovative therapies and products for our patients.

Patient needs, stakeholder demands, industry innovation, regulatory landscape, and Abb Vie’s evolving business strategy create a complex, rapid‑paced, dynamic environment. Emphasizing and embedding quality in the execution of clinical trials ensures data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs.

The Director, Clinical Quality Assurance is responsible for developing and implementing global strategic quality oversight for Therapeutic Areas (TAs) within clinical development programs. This role ensures that R&D complies with corporate policies and worldwide regulations. The position provides strategic leadership, guarantees inspection readiness, and delivers comprehensive QA perspectives for assigned TAs. It influences decision‑making processes to embed quality requirements within improvement initiatives, with a focus on proactive quality.

The director supports Clinical Development globally to ensure quality excellence, data integrity, and the realization of R&D goals for submission of new therapies, adherence to the Abb Vie Quality System, and execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards). Scope includes R&D and clinical research activities for the R&D pipeline to achieve first‑pass approvals, advancing the pipeline.

The position will report to the Senior Director, Clinical Quality Assurance.

This role could be based in Abb Vie’s Lake County, IL / Irvine, CA / EU / UK.

• Deliver innovative quality strategies and solutions through collaboration within RDQA and R&D personnel, all levels of Abb Vie management, other GxP functions, and external service providers to support effective and timely solutions.
• Build a strategic, high‑performing team within the TAs that leverages their understanding of the TA, programs, and upcoming development milestones to embed quality into development programs early, prevent risks that could impact submissions and approvals, and increase success during GCP inspections.
• Partner with Vendor QA and AREA QA to uphold the core GCP principles across the QA matrix supporting development, engaging across QAGxPs and delivering mitigation strategies to critical business partner networks.
• Develop a sustainable, collaborative relationship with clinical development leaders and organizations to ensure, promote, and guide Abb Vie quality systems and objectives, maintaining alignment with R&D and RDQA goals.
• Drive development, continuous improvement, and implementation of necessary GCP systems by leading or collaborating on cross‑functional initiatives to assure compliance with regulations and corporate policies.
• Analyze and evaluate processes that support clinical development to assure quality and compliance; lead and develop a team of Program Managers per therapeutic area in the execution of comprehensive quality assurance plans, performance, and ways we work to achieve results.
• Maintain two‑way dialogue with stakeholders regarding work assignments and results, fostering a culture of excellence and clear communication of expectations.
• Lead strategic planning to ensure resources are available for essential quality assurance activities.
• Provide…