Global Quality Lead

UCB - Union Chimique Belge

Braine l'Alleud, Belgium

About the Role

You will provide leadership and QA expertise to manage the lifecycle of products available on the market including submissions, launches, product improvements, and phase-outs.

What You Will Do

You will represent Global Quality within the Technical Satellite Team.
You will be responsible for the quality resources and capacity for projects associated with the product.
You will support the preparation and execution of product launches from a QA perspective.
You will review and approve CMC sections related to regulatory submissions, renewals, or variations.
You will be the Global Quality contact for regulatory inspections related to the product.
You will review and approve the Product Stability Strategy and Annual Stability Plan.
You will manage the Product Change Control Committee.
You will represent the Product at Technical Meetings with Senior Management and at Recall Committee
You will define and establish key performance indicators for QA activities and services associated with the product.

Interested? For this role, we are looking for the following education, experience, and skills

Degree in science, engineering, or a related field.
Minimum of 5-8 years of experience in the pharmaceutical/biologics industry in quality management.
Good knowledge of GMP regulations and CMC regulatory requirements.
Experience interacting with regulatory bodies regarding QA systems and inspections.
GMP auditing/inspection expertise.
Excellent communication and problem-solving skills.
Ability to work effectively in a matrix and multicultural organization.

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