Director, QA R&D - PV Audits

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: The Director of Pharmacovigilance Auditing is responsible for implementing a comprehensive audit program and leading a high-performing team of audit staff to assure AbbVie’s Pharmacovigilance (PV) system has proper quality, integrity and controls via strategic audit oversight. Audit management includes auditing, people leadership/development and compliance reporting where required.

This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role includes strategic leadership of Audit Programs to assure compliance, external audit of AbbVie and inspection readiness across the scope of our Portfolio, global footprint and the foundational connections of our complex PV System. Provide consistent and aligned consultation to R&D leadership stakeholders from multi-functional interactions with a focus on audit management, risk decisions, metric/process reporting with a data-driven, comprehensive quality perspective. Influencing the decision-making process to drive foundational quality requirements into process, issue and risk management and inclusion within process improvement initiatives.

This position is accountable to the leader of the Internal Audit function for R&D Quality. The decisions and recommendations made by the individual will directly assess the controls in place and will impact actions assuring adherence to applicable regulations and thereby promote the continued success of R&D. Core competencies expected for this role: Quality management, Audit program management, Strategic and dynamic team leadership, Critical communication skills, Functional expertise and Analytical aptitude for the subject matter.