Manager, Validation Quality Systems

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 Manager Validation Quality Systems is responsible for providing quality assurance support to pharmaceutical products, cosmetics and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support include Validation Documentation, Change Management and CAPA. This position will also translate strategy into tactical objectives to deliver strategic plans. This position will ensure that all product, process or system related quality activities re in compliance with Corporate and governmental regulations.

Responsibilities

• Ensure proper integration and support of quality regulations for Active Pharmaceutical Ingredients (API), biologics and cosmetics
• Lead project teams in planning, preparation, review and approval of quality documentation.
• Responsible for implementing and maintaining the effectiveness of the validation quality system in compliance with Corporate policies, processes and procedures.
• Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present validation data for management or during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Manage and oversee a group of validation engineers
• Support new product introduction for pharmaceutical products
• Support design and validation changes to existing products.
• Interact with internal and external partners for development of best practices in our validation quality systems and procedures.
• Perform assessments to determine compliance to validation processes and regulations to identi