Quality Site Head

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 Site Head is responsible for the effective operation of QA functions at the manufacturing plant including Incoming Quality Assurance, quality control testing of the product, Manufacturing Quality Assurance of in-process and finished product including batch record auditing and disposition. Validation of product, processes and equipment. Leads a team of quality professionals who are responsible for compliance and quality oversight for the plant operations.

Responsibilities

• Responsible for all aspects of quality assurance and quality control related to product(s) produced at the plant. 

• Represents the decision-making authority on all aspects of the Quality and Regulatory compliance program for the site.

• Provides overall quality direction to the Site Director and the plant staff on the product fitness for use criteria.

• Ensure that product within the plant is consistently manufactured in conformance with product requirements and all applicable regulatory requirements.

• Manages a quality organization of up to 7 direct reports.  Directly responsible for the effective organization, administration, training and supervision of the Quality Department.

• Provides regulatory and technical guidance to all departments in the plant.

• Represents the site in matters associated with governmental / regulatory investigations and inspections.

• Responsible for the development and administration of the annual operating budget of the Quality Department.

• Follow-up on short term and permanent corrective action for all non-conforming products or situations with potential impact on product performance. Responsible for the timely