Sarepta Therapeutics Job Trends

The Sr. Manager, Corporate Quality Audits, provides GxP oversight for the vendor management and audit program, with primary responsibility for GPV and GLP/GCLP vendor audits. The role ensures compliance with FDA, ICH, OECD, and other global requirements, supports the integration of acquired programs, and drives continuous improvement of quality systems. The Opportunity to Make a Difference Primary responsibilities include · Conduct GPV and GLP/GCLP external audits of Sarepta approved vendors. Develop audit plans, conduct quality audits, prepare audit reports, and communicate and escalate findings, including compliance risk. · Conduct Quality Audits associated with qualification of new vendors. · Conduct for...

The Senior Clinical Operations Lead, Clinical Operations manages all aspects of assigned clinical trials as well as the study project plan, including timeline, budget, and vendors and is expected to conduct large studies of high complexity. The Sr. COL will provide leadership and potentially line management within Clinical Operations and guidance with regards to operational deliverables The Opportunity to Make a Difference Oversees Clinical Research Organizations (CROs), vendors and consultants involved with the clinical trials Serves as the point of contact for protocol execution and leads the Clinical Trial Team (CTT) Mentors junior team members and ensures...

The Associate Director, Commercial Analytics and Business Operations leads standardized and ad-hoc data reporting activities in support of the Commercial organization. This includes dashboards, Executive Performance reports, and ad-hoc data requests. This position partners cross-functionally to ensure the most actionable and efficient reporting possible. This role has broad commercial exposure to Sales Effectiveness, Data Management, Patient Services, Diagnostics, and Site Readiness. This is a hybrid role with 1-2 days per week in Sarepta’s Cambridge office. The Opportunity to Make a Difference Primary Responsibilities Include · Develop Commercial Reporting strategies and objectives; operationalizes strategy into specific tactics and executes deliverables. ·...

The Sr. Director, Corporate Quality, Pharmacovigilance will be responsible for the management of GVP quality oversight, GVP-related audit program and for providing regulatory/GVP guidance. The Opportunity to Make a Difference This position will liaise with internal groups such as Pharmacovigilance Operations, Safety Evaluation & Risk Management, and Market Research, as well as external groups including contract auditors in an effort to ensure a high level of quality and consistency across the Sarepta platform; design and oversee the audit strategy; assist the GVP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support...