Senior Manager, Quality Control

Primary Responsibilities Include: 

•  Primary liaison for quality control activities between Sarepta and Contract Manufacturing Organizations 

• Support release, stability, and trending programs 

• Support initiation and review of change controls, deviations, CAPA 

• Support the cross functional CMO support team  

• Support regulatory submissions and inquiries 

• Assist in writing and reviewing quality documents such as test methods, SOP, change controls, and investigations originated internally as well as at the vendor sites.  

• Perform other related duties incidental to the work described 

• Be located at the CMO for a majority of the work week 

Desired Education and Skills:  

• B.S. or M.S. in chemistry, biology, microbiology, virology or related field with at least 7+ years relevant experience in QC GMP environment.  

• A strong technical background and proven track record in Quality Control with methods related to cell biology, biochemistry, and molecular biology. 

• Experience managing direct reports  

• Experience authoring policy documents, SOPs, protocols, and reports. 

• Technical knowledge of and experience in routine quality control tests such as, but not limited to qPCR, SDS Page, compendial methodology, etc 

• Strong understanding of cGMP/ ICH/ FDA/ EU regulations. 

• Experience with auditing bodies and regulatory filings 

• Ability to work cross functionally with several internal and external partners. 

• Operational Excellence focus and expertise