AbbVie - North Chicago, IL
posted about 2 months ago
The Director of Product Quality at AbbVie is responsible for ensuring the overall quality of AbbVie products, which may include small molecule pharmaceuticals, biologics, and combination products. This role is crucial in meeting business objectives related to the timely delivery of products while ensuring compliance with local, divisional, and corporate policies, as well as external agency regulations worldwide. The scope of responsibility extends to business processes that support new product introductions, product monitoring, and post-market quality systems. The products under this role include regulatory starting materials, Active Pharmaceutical Ingredients (API), intermediates, and drug products produced by AbbVie plants or third-party manufacturers, as well as those involved in in-licensing or co-marketing relationships. In collaboration with Regulatory Affairs, the Director develops appropriate regulatory strategies for product brands. The position requires leading a team of quality professionals responsible for on-market product support, including quality monitoring, supplier quality, and post-marketing quality assurance. The Director will also be a core team member or lead of strategic programs, which include Brand Teams, Product Transfers, Global Strategic Sourcing, and Continuous Improvement initiatives. A significant aspect of the role involves developing and implementing a global Product Quality Assurance strategy to support pharmaceutical, biologics, and combination products manufactured at AbbVie plants or third-party facilities. This includes ensuring alignment of Quality and Technical Agreements with legal contracts and managing the organization’s actions within the legal boundaries of these documents. The Director is a key decision-maker on product quality and regulatory conformance issues, responsible for reviewing and approving plant Quality Assurance performance reports and financial plans. This role also involves directing Quality Assurance initiatives for global sourcing projects, reviewing and approving budgets, and interfacing with internal audit teams to develop audit plans and maintain a corrective action timetable. Additionally, the Director monitors manufacturing operations for compliance with established procedures and good manufacturing practices, and develops global strategies related to product complaints management and stability assessment for all products globally.