Global Analytical Project Lead

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

The Global Project Lead is a pivotal and influential role within our organization, responsible for shaping and supporting the clinical pipeline with a strategic focus on the analytical testing domain. This role is paramount in providing comprehensive governance over the method lifecycle, ensuring that analytical methods and processes are robust, fit for purpose, and effectively aligned with our global commercial strategies and Quality Control Laboratories' standards.

Responsibilities

Governance and Oversight:

• Relevant analytical Lab experience in Biologics Testing
•  Lead the governance framework to ensure future commercial methods are globally fit for purpose, robust, and optimized for full-scale manufacture, influencing quality on a global scale.
• Oversee the development and validation of analytical methods for new product introductions (NPIs), ensuring they meet global standards.
• Provide high-level technical support throughout the method lifecycle, guaranteeing alignment with our strategic goals and quality expectations.
• Maintain an up-to-date and in-depth understanding of global regulatory requirements influencing product testing and development, ensuring compliance and proactive strategy adaptation.

Method Development and Transfers:

•  Deliver quality oversight across the lifecycle of methods, ensuring they comply with global regulatory standards and align with organizational business objectives.
• Manage and oversee seamless method transfer processes to and between Biologics sites worldwide, ensuring integration, continuity, and quality consistency.

Data Integrity:

• Ensure the integrity and accuracy of