Head of Analytical Compliance Lead - PDS&T

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

Responsibilities:

• Sets up, leads and develops a team responsible for Quality Control Coordination, Quality Compliance, Exception and Change Management, Qualification and Maintenance and, analytical Outsourcing.
• Develops and implements short and mid-term strategy for the Compliance group and manages effectively local and global interfaces (within PDS&T, with Operations QC, R&D and Ops QA, Development Sciences, Regulatory, etc.).
• Develops/aligns local processes/workflows and GMP approaches within PDS&T LC
• Develops/aligns in close cooperation with other PDS&T sites and partner organizations global lean processes/workflows and GMP approaches cross-functionally.
• Manages effectively local/global interfaces (Operations QC, R&D and Ops QA, Development Sciences, Regulatory, etc..) and drives cross-functional alignment. Initiates and/or contributes to global cross-functional initiatives to improve processes and workflows.
• Is responsible for GMP systems and processes, and compliance within area.
• Drives/coordinates local and global initiatives to align and improve processes and workflows.
• Ensures utilization of appropriately risk based approaches to ensure project and internal/external budget success and increase efficiency.
• Drives technological innovation and guides improvements to leverage operational excellence within function and in line with the PDS&T vision.

Leadership Competencies: 

• Is up to date on regulatory expectations (guidelines, GMPs and other GxPs as appropriate) and translates these into executable approaches aligned with partner functions.
• Builds strong relationships with peers to create and