Manager, Design Quality - Late Stage Development

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 New Product Introduction (NPI) 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, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, marketing, Product Development and other cross-functional stakeholders.

Responsibilities:

• Serves as the primary quality lead 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.
• Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations.  Responsible for compliance with company policies and procedures.
• Perform design control activities: Mentor/lead product team members through the design process providing guidance to assure optimal approach. Work closely with research organization to ensure potential product issues are identified and addressed in the design.  Assure robust product vs. customer requirements.  Ensure interfaces to drug development where appropriate.