Quality System Lead -CAPA & Training

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 Quality Systems Lead for CAPA & Training provides leadership and direction to the manufacturing site.  This role is responsible for the effective implementation of the Quality systems and is expected to be lead improvement initiatives, maintain the site in state of compliance and lead the site to meet the quality metrics for CAPA and training.

Responsibilities:

•Leads and influences peers and colleagues to ensure CAPA and training metrics are met.

•Responsible for various aspects of quality assurance related to products produced at the plant.

•Responsible for the effective organization, administration, and training within the QA organization

•Independently troubleshoot and resolve quality compliance issues.

•Provides regulatory and technical guidance to departments.

•Communicates with Management for Quality Management Review, Quality Initiatives, etc.

•Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.

•Responsible for the Quality Onboarding and Training including implementation of improvement programs.

Qualifications

Qualifications:

•Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
•8+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
•Must be familiar with use of electronic document management and laboratory information management.
•Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements.
•Strong communication Skills, both oral and written
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