Senior Manager, CQA Audit (JAPAC)

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Purpose

The Sr. Manager, Clinical Quality Audit is responsible for the execution of the Clinical audit program globally, including scheduling, planning, reporting and resolution of all types of Clinical audits and assure the quality and compliance of AbbVie clinical trials and studies across all regions.

- Supports Clinical Quality Audit leadership with the strategic direction of the Clinical Quality Audit program to ensure business objectives are met, drive key performance indicators, and lead complex improvement projects to ensure efficiency and effectiveness.
- Assures quality and compliance in a regulated environment including AbbVie policies and procedures, country specific requirements, and other applicable standards and worldwide regulations.
- Advances the AbbVie Quality System through robust collaboration with business partners and other GxP RDQA functions and implementation of systems and processes required to support global quality assurance requirements.

Responsibilities

Partner with Clinical Quality Assurance and Clinical Development Operations to understand development programs and related risk factors to drive audit planning, site selection, & scheduling.; Oversee and manage the external suppliers/contractors conducting audits on behalf of AbbVie. This may include providing information about company processes, known quality issues, audit scoping expectations, and/or audit guidance.; Plan and conduct more complex internal audits as well as external routine and for-cause GCP audits worldwide.; Drives development/continuous improvement of necessary quality and clinical systems by leading and/or supporting implementation of initiatives to assure compliance to regulations and corporate policies.; Analyses and evaluates processes that support clinical development in order to assure quality and compliance.; Provides expert advice and support on clinical regulations, guidance and expectations to RDQA and business colleagues including external contractors, clinical investigators, and development partners on topics related to clinical trial conduct, to facilitate identification and resolution of GCP-related issues and concerns.; Guide functional teams through the CAPA process to ensure robust investigation, timely action, and meaningful improvements to process.; Using quality management system tools, analyze audit findings and trends to drive continuous improvement.; Train staff on regulatory requirements, quality management processes and procedures.; Provide inspection support for GCP inspections onsite or remotely if needed.

Requirements

Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience.; 5-7+ years of experience in the pharmaceutical industry in the fields of clinical development, clinical trials regulatory affairs and/or quality assurance supporting those areas, or with a regulatory authority; Detailed knowledge of quality systems and auditing standards with experience in GCP auditing.; Extensive knowledge of worldwide clinical regulatory requirements and industry best practices, quality management principles, including global and regional regulations and internationally recognized standards (e.g. ICH, ISO).; Excellent communication skills, including superior negotiation and influencing skills. Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference. Ability to manage difficult conversations and seek alignment.; Ability to manage complex issues and distil information. Strong analytical skills and the ability to proactively identify, rapidly assess, and effectively manage business and compliance risks.; Demonstrated flexibility to adapt to changing assignments and ability to effectively prioritize.; Ability to think strategically and communicate effectively with colleagues at all levels, including senior management.; Well-developed leadership competencies to deliver team objectives and projects. Willingness and ability to perform domestic and international travel.