Associate Director, Medical Affairs Quality Assurance

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

Purpose

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality 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 for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution of clinical trials, post market vigilance and post market studies, assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs.

Associate Director, Safety, Medical & Regulatory Quality is part of the R&D Quality Medical Affairs (MA) QA team which provides independent quality oversight of AbbVie’s Medical Affairs and Health Impact (MHI) function and other functions engaged in Real-World Evidence (RWE) generating activities. The role covers AbbVie’s entire portfolio of drug, device and cosmetics. The role ensures quality excellence through successful business partner collaboration and provides expert technical quality support and consultation to R&D colleagues and business partners. May support Regulatory Agency inspections.

The role reports to the Director, Safety, Medical & Regulatory Quality. There is an expectation that in performance, leadership