Manager, Standards & Compliance I

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

Compliance Manager, Clinical Process Compliance is accountable for the interpretation and application of GCP compliance and quality principles as they relate to clinical trial execution. Responsible for facilitating impact assessments of regulatory intelligence working with business partners to translate regulations and requirements into execution of high quality clinical trial conduct.  Acts as Primary Point of Contact for all GCP compliance-related questions and issues, leading the clinical trial issue escalation process to mitigate serious issues cross-functionally across R&D. Manages capture and closure of issues, risk assessments, potential non-conformities and non-conformities, and effectivity checks. Provides GCP compliance support for site and sponsor inspections, and process and system audits. Supports Clinical Trial Business Continuity (BCT) efforts across R&D during times of crisis.  Demonstrates excellence in collaboration, communication and working in a matrixed environment.

Responsibilities:

• Responsible for compliance with applicable Corporate and Divisional policies and procedures.
• Provides management of clinical compliance, quality and standards projects within Clinical Operations; prepares key performance indicators.
• Provides input on new/updates to SOPs, guidelines, work instructions as well as make initial gap assessment of impact of new regulations.
• Effectively communicates project progress/compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues.

Qualifications

• Bachelor’s degree (or ex-US