Director, Clinical Process Compliance

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

Drives vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. Ensures clinical studies are successfully implemented through a strong foundation of GCP Compliance, governing quality system documentation, and quality control of processes. Accountable for the end-to-end Clinical Trial Business Continuity process and escalation of business-critical decisions to Senior Leadership across R&D during times of crisis. Instills an Inspection Readiness culture enabling natural everyday compliance in support of successful inspection outcomes and on-time product approvals. Accelerates patient impact by delivering operational excellence to meet evolving business needs through collaborative partnerships, and a proactive, balanced, and innovative compliance approach. Demonstrates excellence in people leadership and development, and working in a matrixed environment.

* This role can be hired globally. 

* If a candidate resides within a commutable distance to the North Chicago office, there will be a hybrid onsite expectation.

• Effectively identifies and leads high performing team of GCP Compliance experts who position the organization for successful clinical trial execution outcomes including inspection success and on-time product approvals.
• Partners with Development Leaders to align on strategy for delivery of GCP Compliance and quality principles to meet immediate and evolving business needs and regulatory expectations.
• Instills a culture of Inspection Readiness across the Development organization through a pro-active and balanced compliance approach.
• Develops the strategy and operational approach for inspection preparati