The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA working within a CMC sub team structure and serving as a member of the GRT. The Senior Manager will a

The Manager, Medical Reviewer provides operational oversight of medical materials review within the Medical Affairs function reporting to the Director of Global Medical Review. This individual works closely and effectively with key members of internal departments including Marketing, Legal/Compliance, Regulatory, Medical Affairs and Clinical Development to assure that all

The Global Market Access Contractor is responsible for the development of global market access strategies for Sarepta's assets in alignment with the broader International Business Unit goals and priorities. This position requires proactive participation in cross functional teams, demonstration of strong leadership and strategic thinking and ability to manage multiple proje

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 Sr. Manager, QA Auditing will be responsible for scheduling and leading domestic and international Corporate and Regional Compliance Audits, including internal audits of Sarepta GxP facilities and external audits of Sarepta approved vendors in accordance with Sarepta policies and procedures. He/she will proactively identify compliance risks and communicate to Sarepta l

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 Real World Evidence (RWE) Contract Epidemiologist will provide leadership for scientific prospective and retrospective activities in the RWE team supporting Sarepta. The RWE Contract Epidemiologist will function in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Qu

As a member of the Analytical Development group this position is responsible for performing GLP method validation and GLP analytical assay support for early stage research programs. The individual will collaborate with Early Research Process Development, Gene Therapy Research, and additional internal and external stakeholders to support nonclinical GLP studies. Primary Res

The MSL will play a pivotal role in the education of healthcare professionals (HCPs) about Duchenne Muscular Dystrophy and Limb Girdle Muscular Dystrophy as well as Sarepta's investigational therapeutics and product pipeline. Reporting to the West Region Team Leader, the MSL position will play a pivotal role in the education of healthcare professionals (HCPs) about Duchenn

Sarepta Therapeutics is looking for an energetic and resourceful HR Informations Systems Technical Analyst. As an HRIS IT Technical Analyst, you will play a crucial role in supporting and optimizing our Human Resource Information System (HRIS), with a specific focus on Workday. Your expertise will be essential in ensuring smooth system operations, data integrity, and effec

The Senior Manager, Business Development effectively evaluates, analyzes and supports execution of strategic transactions to build the future of Sarepta through Business Development. Sarepta has become the partner of choice for genetic medicine companies globally and we intend to accelerate our already substantial BD activity going forward. The Senior Manager competently p

The Scientist I, Bioinformatics works closely with several groups within Sarepta's Research and Development department. The Scientist I, Bioinformatics is part of the Genomics and Data Sciences team and plays a critical role in supporting Discovery Biology to advance our portfolio of RNA, gene therapy, and CRISPR based gene editing therapies to treat neuromuscular and CNS

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 Director of QCTS is responsible for overseeing the operations of the internal molecular and cell based assay teams. The individual will support method validation and transfer activities conducted at Sarepta in compliance with cGMP regulations. Additionally, this role will provide oversight of method development and validation activities conducted at the contract test l

The Associate Director, R&CD Quality Assurance will be responsible for the delivery and execution of the Sarepta internal and external audit program, risk based audit plan development, and the conduct of GLP/GCP/GVP audits. The Associate Director will participate in vendor risk assessment and vendor qualification, GxP audit consultation management, and the development of p