Purpose

The Quality Systems Director serves as a leading subject matter expert and project manager for the continuous improvement of the AbbVie Quality System. As such, the QS Director must maintain current subject matter expertise in the latest developments in global pharmaceutical quality systems. In addition, the QS Director must be able to integrate and facilitate the formation of the Device Quality System both as a part of the AbbVie QS and as individual plant quality systems. The QS Director also serves as the Operations Coordinator of the Regulatory Intelligence Process. As such, they are responsible for the capture, dissemination and implementation of technical and regulatory new global guidelines and emerging regulations.

Responsibilities

• Serve as Operations Quality Plan Coordinator and ensure compliance with all quality plan requirements for both drug and device quality systems.
• Participate and lead long-duration teams formed to drive process harmonization, site-to-site consistency, sustainability and efficiency.
• Complete all transition activities for company separation duties; particularly for document hierarchy across the three functional areas.
• Manage the Quality System and Centers of Excellence to ensure alignment with regulatory standards and guidance. Drive a continuous improvement philosophy to ensure the CoEs are being managed to deliver a quality system that consistently meets regulatory requirements. Drive alignment of CoE activities with the Global Operations Quality strategy.
• Serve on short duration teams chartered with achieving synergies with other Quality organizations (e.g.-R&D and Regulatory).
• Serve as a key leader in knowledge management processes via Regulatory Intelligence Process that better enable AbbVie to achieve an improved, current and contemporary quality system.