Associate 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

Responsible for quality of assigned Biological, and/or Gene Therapy products 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 regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Acts as the primary quality representative for the global supply chain pertaining to external manufacturing business relationships and builds and maintains relationships with TPM Operations, Supplier Quality Management, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and PDS&T to ensure alignment

Responsibilities

• Support Quality 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 new product launches including Third Party Manufacturer’s that provide products directly to distribution centres, or to AbbVie domestic and International plants for further packaging and/or testing. 
• Supports control strategy QA oversight for selected Biological, Neurotoxin and Gene Therapy products with continuous improvement and efficiencies in mind. Will collaborate with strategic partners to ensure right first time goals are achieved.
• Primary Quality contact between third party manufacturers, R&D and AbbVie Operations in support of commercial operatio