Director, Product Quality

AbbVie - North Chicago, IL

Full-time - Senior

North Chicago, IL

Chemical Manufacturing

About the position

The Director of Product Quality at AbbVie is a pivotal role responsible for ensuring the overall quality of AbbVie products, which may include small molecule pharmaceuticals, biologics, and combination products. This position 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's purview 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 licensing and co-marketing relationships. In collaboration with Regulatory Affairs, the Director will develop appropriate regulatory strategies for product brands. The role 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 for strategic programs, which encompass Brand Teams, Product Transfers, Global Strategic Sourcing, Post-Market commitments, Due Diligence, Site Selection, and Continuous Improvement initiatives. The Director will implement a global Product Quality Assurance strategy to support pharmaceutical, biologics, and combination products manufactured at AbbVie plants or third-party manufacturing 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 role also involves liaising with various functions such as Research and Development, supply chain, medical safety evaluation, and commercial functions to address marketplace issues recognized by operations management. As a key decision-maker on product quality and regulatory conformance issues, the Director will review and approve plant Quality Assurance performance reports and financial plans, directing Quality Assurance initiatives for global sourcing projects. The position requires monitoring manufacturing operations for compliance with established procedures and good manufacturing practices, as well as developing and executing global strategies related to product complaints management and stability assessment for all products globally.

Responsibilities

• Lead a team of Quality professionals responsible for assigned products and/or business processes required for on-market product support.
• Core team member or lead of strategic programs including Brand Teams, Product Transfers, Global Strategic Sourcing, Post-Market commitments, Due Diligence, Site Selection, and Approvals and Continuous Improvement.
• Develop and implement a global Product Quality Assurance strategy to support pharmaceutical, biologics, and combination products manufactured at AbbVie plants or third-party manufacturing facilities.
• Support development of legal supply agreements, contracts, and letters of intent to ensure appropriate quality, compliance, and regulatory aspects are met.
• Approve negotiated quality and technical agreements as a representative of AbbVie.
• Ensure business objectives are met regarding on-time delivery of product and budget compliance while assuring adherence to local and divisional policies.
• Liaise with Research and Development, supply chain, medical safety evaluation, and Commercial functions to recognize marketplace issues.
• Key decision maker on product quality and regulatory conformance issues; review and approve plant Quality Assurance performance reports and financial plans.
• Direct Quality Assurance initiatives for global sourcing projects.
• Review and approve budgets; interface with internal audit teams to develop audit plans and maintain a corrective action timetable.
• Monitor manufacturing operations for conformance with established procedures and good manufacturing practices.
• Develop and execute global strategies related to product complaints management and stability assessment for all products globally.

Requirements

• Graduate Degree in Life Science or other technical discipline required.
• 15+ years of total combined relevant experience, including at least 2 years of plant experience and at least 5 years in Operations, Research and Development, or Technical experience.
• Plant operational leadership experience preferred.
• Expert knowledge and a comprehensive understanding of biological and/or pharmaceutical technologies.
• Ability to understand and overcome cultural and language obstacles to provide solutions that satisfy both functional and local objectives.
• Capable of analyzing data and directing the development of effective action plans, as well as problem-solving.