Quality Control Senior Manager

Job Description

General Summary:

The Quality Control Senior Manager will be responsible for supporting the establishment and oversight of a new QC centralized external contract lab and management of existing contract testing labs.  The position will manage GMP release and stability activities in support of clinical and commercial biologics programs while ensuring compliance with SOP’s, policies, and industry guidance.  In addition, this role will help support the  transfer/validation of GMP analytical methods, participating in establishment and implementation of internal Quality Control systems, processes and procedures in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations.  This role will interact with internal cross-functional teams and our network of external CMOs/contract labs to ensure that all GMP analytical methods for lot release and stability testing of drug substance and...