Director, Quality Systems

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 Statement 

This role serves to provide leadership in the Quality Operations function to support and drive strategic initiatives, continuous improvement and management of the Quality Center of Excellence in cooperation with the Center of Excellence leads. This position holder will hold responsibility for working closely with regulatory intelligence team and improve AbbVie Global Quality System by ensuring external and internal regulatory and business signals are translated into improvements of the different Quality System elements to consistently deliver compliance and high-quality product. These signals include new or changed external regulations, observations from AbbVie´s regulatory inspections and competitor’s enforcement actions, AbbVie´s strategic objectives and continuous improvement needs.  The responsibilities, qualifications and experience required for this position are presented below.

Major Responsibilities:

• Provide directions, leadership and guidance to the Center of Excellence Leads (CoE) in a matrix organization (currently 18 global CoE Leads, mostly on a Director- or Associate Director level across 20 Centers of Excellence)
• Manage the Quality System and Centers of Excellence to ensure alignment with regulatory standards and guidance. Drive a continuous improvement philosophy to ensure the CoEs are being managed to deliver a quality system that consistently meets regulatory requirements. Drive alignment of CoE activities with the Global Operations Quality strategy.
• Own, drive and continuously improve the process to identify relevant enforcement actions of key regulatory agencies including FDA, EMA, MHRA, HPRA for AbbVie's peers. In collabor