The Executive Director QC leads a high functioning QC group comprising 35 40 individuals and 3 direct reports. The ideal candidate should be highly skilled in managing external manufacturing and testing sites both in the USA and across the world. The successful candidate will foster a collaborative environment and play a key role in developing and executing the strategy fo

The Sarepta Therapeutics QA Compliance Unit is seeking to fill a Full Time position for Manager, Quality Engineer to develop and maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies. Develop and maintain processes to facilitate QMS record completion through overseeing and enabling proper investigation including problem

The Quality Control Analyst will work within the QC team, testing gene therapy products utilizing cell based assays (Potency assay) in support of clinical and commercial lot release and stability activities. These assays are conducted in house at the Sarepta facility in Andover, MA., with additional testing performed at contract testing laboratories (which may require peri

The QC Data Manger will be responsible for overseeing review for accuracy and interpretation of data generated internally from testing laboratory charged with the execution of all GMP bioassay and Nucleic Acids Testing (release and stability) related to Sarepta's Gene Therapy pipeline. The Data Manager will be responsible for oversight and review of release and stability d

The Sr. Manager, GxP Training position is responsible to manage Sarepta's global GxP Training Program. The position will reside on site in the Andover, MA facility, reporting to the Director of Global Quality Systems. The position encompasses a variety of training management responsibilities, including maintaining a compliant GxP Training Program in accordance with US and

This individual will support routine testing conducted at Sarepta Andover laboratory charged with the execution of Nucleic Acids Testing (release and stability) related to Sarepta's Gene Therapy pipeline conducted internally. The individual will conduct GMP QC release and stability testing using state of art Quantitative Polymerase Chain Reaction, qPCR, Droplet Digital PCR

This individual will support method development, validation, and quality control activities conducted at Sarepta Andover in compliance with cGMP regulations. The individual will devise, troubleshoot, and validate cell based assays to assess the critical quality attributes of AAV gene therapy products including potency and infectivity. This role would facilitate activities

The Associate Director, QC Cell Culture and Bioassay will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta' s Gene Therapy pipeline. The Associate Director will build and oversee a team of eight to ten QC technicians with responsibilities that include but are not limited to