Product Quality Manager-Combination Products

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

Responsible for quality of assigned combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories.  Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships.  Develops the appropriate regulatory strategies for product brands in concert with Regulatory Affairs.

Responsibilities:

• Serves as the primary quality lead with management oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.
• Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities.  Implements agreed strategy.
• Participates on New Product teams to bring combination products and medical devices through the Design Control process to deliver on-time product launches.  Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to AbbVie domestic and international plants for further packaging and/or testing.
• Makes recommendations for key decisions on p