Manager, Design Quality Lifecycle 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
Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market. Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc. 

Responsibilities

• Primary driver for the quality and compliance aspects of Design transfer and on-market change management.
• Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie.
• Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.
• Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor to ensure timely closure.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
• Assist 3rd party suppliers during change management process, including change management strategies.
• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation.
• Support the preparation of regulatory inspections and internal a