Senior Auditor, GVP Audit & Compliance

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. Assures quality and compliance in a regulated environment through audit and QA consultation activities. Leads PV audits (internal system and/or process, affiliates and third parties) to ensure compliance. Communicates audit results effectively. Assists in the design, planning and execution of risk-based methodologies. Advances the AbbVie Quality System. Supports PV inspections and License Partner audits.