Senior QA Manager, North Carolina

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Senior QA Manager

CDMO

Greensboro, NC

A partner CDMO of RBW are in the process of building their capabilities to include Biologics! They are looking for a strong Quality minded individual to join their team as aSenior QA Manager.

Working closely with teams across the business, you will advise and help to drive the expansion of the Biopharma business unit. Interfacing with clients and guiding them through the lifecycle of their product, specifically in the early phases and with particular reference to Regulatory processes.

This is an exciting opportunity to join a growing and ambitious business, with clear objectives for the upcoming years.

Qualifications

• 7+ years of experience in QA management, preferably in biologics or gene therapy.

• In-depth knowledge of GMP, FDA, and EMA regulations.

• Well versed in 21 CFR 210, 211, 600, and 610