Director, Product Quality

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 overall quality of AbbVie products including small molecule pharmaceuticals and/or biologics, combination products, and medical devices—complying with delivery time objectives; local, divisional, and corporate policies; and ext. agency regulations worldwide. Scope of responsibility can also include business processes supporting new product introduction, product monitoring, or post-market quality systems. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), produced by AbbVie or third-party manufacturer Intermediates/Drug Products. Acts as the principle, quality, global supply chain rep. with external manufacturing businesses. Builds and maintains relationships with TPM Operations, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to align strategic initiatives. Develop regulatory strategies for brands with Regulatory Affairs. 

Responsibilities

• Develop and lead a quality professional team responsible for assigned products’ transfer activities and end-to-end product quality—conforming to worldwide standards/regulations throughout the NPI supply chain & departmental budget. Lead Product Quality Assurance Transfer Mngr.s to develop strong relationships with Third Party Manufacturers, AbbVie plants, affiliates, & other functional groups. Help them understand each project’s quality, compliance, & org. resource needs; & align roles and res
• Ensure delivery of all quality elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to AbbVie