About the job
The Senior Quality Manager, responsible for the Incoming Quality Assurance (IQA) and Supplier Quality Assurance (SQA) functions, plays a pivotal role in providing leadership and direction to the Quality Function within Operations. This senior management position entails overseeing the successful implementation of AbbVie’s Quality Systems. Key responsibilities include: ensuring adherence to corporate quality standards for drugs and packaging materials, managing manufacturing quality assurance, validating products and processes, and leading initiatives in quality engineering, quality control, training, regulatory compliance, quality planning, and product quality. The Senior Quality Manager will lead a talented team of quality professionals tasked with ensuring compliance and maintaining high-quality oversight throughout the plant and associated strategic initiatives. A fundamental expectation of this role is to uphold exceptional quality levels across all products while optimizing operational efficiency.
- Oversee various aspects of quality assurance and quality control related to high-volume, complex product manufacturing within the plant.
- Act as the decision-maker for quality and regulatory compliance programs at the site.
- Ensure products are consistently manufactured according to corporate quality standards and regulatory requirements.
- Lead and manage a team of quality professionals, focusing on effective organization, administration, training, and supervision.
- Provide regulatory and technical guidance across all departments in the plant and serve as the subject matter expert for AbbVie plants.
- Engage with executive leadership on Quality Management Review and strategic quality initiatives.
- Oversee incoming and supplier quality assurance processes.
- Make quality-related decisions impacting plant operations, including facility design, laboratory controls, and product specifications, ensuring compliance with cGMP, FDA, EU, DEA, and other regulatory standards.