Associate Director, Device Quality - 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 injection devices, 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. Acts as the primary quality representative and manages a team of the product subject matter experts (SMEs).

Responsibilities

• Lead a team of Quality Professionals for product transfer activities and direct cross-functional team members to achieve on-time quality deliverables, high customer value, and profitable results.
• Ensures delivery of all quality elements needed to facilitate on-market support for the combination products and medical devices.
• Develops Global Product Quality Assurance strategy and implements agreed strategy to support the products at AbbVie plants.
• Makes key decisions on product quality, compliance and regulatory conformance issues for medical devices and combination products and ensures risk-based elevations to AbbVie leadership.
• Leads the collection, verification and improvement of Quality metrics for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local/global project implementation.
• Leads a team