Senior Auditor, GVP Audit & 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

Purpose: 

Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution of PV audits. Ensuring alignment with RDQA policies and procedures wherever possible and leading the development and implementation of the AbbVie quality system. Leadership and oversight of key audit program (system, process or affiliate) level risk-based decision making to assure a comprehensive audit program. Provision of advice and support on PV and quality topics to business partners to ensure compliance with worldwide PV requirements and expectations.

Responsibilities:

· Assures quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of PV processes through audit and QA consultation activities.

· Lead PV audits (internal system and/or process, affiliates and third parties) to ensure compliance to global regulatory and AbbVie requirements. Effectively communicate audit results, both orally and in writing.

· Assimilates audit observations and compilation of PV audit reports and reviews and approves Corrective Action Plans submitted in response to audit observations within target timeframes. Track actions through to completion.

· Assist in the design, planning and execution of risk-based methodologies to inform the annual PVQA audit plan.

· Advances the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements.

· Contributes to development and continuous improvement of necessary PV systems to