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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Purpose

Responsible for overall quality of AbbVie products which may include small molecule pharmaceuticals and/or biologics, combination 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. Scope of responsibility can also include business processes required to support new product introduction, product monitoring or post-market quality systems. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility.

Responsibilities

• Lead a team of Quality professionals who are responsible for assigned products and/or business processes required for on-market product support (e.g. quality monitoring, supplier quality and/or post-marketing quality assurance).
• Core team member or lead of strategic programs; including Brand Teams, Product Transfers, Global Strategic Sourcing, Post-Market commitments, Due Diligence, Site Selection, and Approvals and Continuous Improvement.
• Develop and implement a global Product Quality Assurance strategy to support pharmaceutical, biologics, and combination products manufactured at AbbVie plants or third party manufacturing (TPM) facilities. Ensures alignment of Quality and Technical Agreements with the legal contracts that the commitments of the quality and technical agreements are being fulfilled.
• Support development of the legal s