The Manager, Quality Assurance provides leadership and direction to the Quality Assurance Function. This Manager role is responsible for the effective implementation of the functions within operations that could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Training, Regulatory Compliance, Quality Planning and strategic initiatives. The Manager of Quality Assurance would be expected to work within a budget and leads a team who are responsible for compliance and quality systems implementation. Expectations that the Manager will maintain high quality levels on all aspects of their job while achieving high levels of efficiency Responsible for various aspects of quality assurance and quality control related to products produced at the plant. Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements. Manages a team with in the quality organization of up to 6 direct reports. Responsible for the effective organization, administration, training and supervision of their functional area. Provides regulatory and technical guidance to departments. Communicates with Management for Quality Management Review, Quality Initiatives, etc. Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs. Manages a team of quality professions, including hiring, setting performance expectations and performance assessment Qualifications. Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering. Certified Quality Engineer or formal training in quality engineering or statistics is preferred 8 years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry. Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant. Must be familiar with use of statistical quality systems, electronic document management and laboratory information management. Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements. Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations. Strong communication Skills, both oral and written. Proficient on Root Cause Analysis and CAPA