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