Manager, Quality Risk Management

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

This individual will be responsible for supporting activities for Combination Products, Pharmaceutical products and medical devices, support the strategic direction to ensure business objectives are met to support and sustain the quality system in Combination Products, Pharmaceutical products, and medical devices and complete quality assurance activities to develop, implement and sustain required regulations to comply to global regulations.

Responsibilities

• Assure proper integration and support of device, drug and Biologics regulations.
• Areas of direct responsibility include development and maintenance of QA procedures for risk management that support AbbVie’s business objectives, functional area strategies, and the overall quality system.
• Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates. Oversee the implementation and management of training programs for pharmaceutical products, medical devices and combination products including leadership, business curriculum and training plans.
• Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing pharmaceutical products, medical devices and combination products.
• Represent AbbVie on External Industry groups where appropriate. Represent AbbVie as the Quality Assurance subject matter expert during internal and external regulatory inspections related to risk management. Work with external and internal partners to establish best in class practices for risk management, validation and other related quality systems for pharmaceutical products, medical devices and combination p