Associate 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
This position defines, implements, and monitors the performance of the systems related to quality assurance. Additionally, this role provides oversight to the supplier quality and quality engineering programs.

Responsibilities

• Interface with Operations QA; Site QA leadership/QPs, Centers of Excellence, Product Quality to ensure connection and providing direction and leveraging affiliate QA knowledge for process improvements.
• Prepare and present data during regulatory audits and internal audits. Lead quality system elements, training, continuous improvement, and tactical support across functions and global affiliate entities.
• Responsible for initiation, selection, coordination, and management of quality system projects. Lead project teams and/or direct staff in planning, preparation, review and approval of quality documentation.
• Interact with internal and external partners for development of best practices in our quality systems and procedures applicable to affiliate operational complexity and regulatory complexity across the global affiliate enterprise.
• Ensures all product, process or system related quality activities at the Affiliate are following Corporate, governmental, and local regulations.
• Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
• Manage a team of quality professionals across the regions, setting performance expectations, providing feedback, development of staff and handling of personnel situations. Ensuring adequate resources and appropriate training to effectively support and meet changing business and compl