Director, Clinical Process Compliance

GCP Compliance And Quality Leader

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 requires onsite work at AbbVie locations. The expected onsite days are Tuesday, Wednesday, and Thursday each week.

Locations : Illinois (IL) : North Chicago, Massachusetts (MA) : Worcester, New Jersey (NJ) : Branchburg, Florham Park, California (CA) : Irvine, South San Francisco

Responsibilities :

Qualifications :

Key Stakeholders :

Senior Leaders within Clinical Development Operations, Regulatory, Quality Assurance, Pharmacovigilance, Legal, Data & Statistical Sciences, Clinical Drug Supply Management, TAMD program and study teams

Compensation and Benefits :

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.