Principal Auditor, Audit & Compliance (Remote)

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

The Principal Auditor, Audit & Compliance provides leadership, direction and performs comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality related systems for AbbVie plants, affiliates, quality service areas and/or suppliers that provide materials, services, and products to AbbVie. Their leadership, direction, and execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness, and safety of our products. This position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.

Responsibilities

• Requires 50-75% Travel
• Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance to regulatory requirements and AbbVie specifications.
• Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained at the supplier or internal AbbVie site. For internal sites, formulates recommendations for corrective actions.
• Leads and participates in strategic initiatives to improve compliance to regulatory requirements and standards.
• For supplier auditing, primarily focused on key suppliers whose processes are more comprehensive and critical to the business and will include potential participation in audits of AbbVie plants.
• Collaborates with R&D QA to coordinate and conduct joint audits.
• Communicates and coor