Senior Manager, Corporate Quality – R&D Audits

Role: Senior Manager, Corporate Quality Audits, overseeing GxP vendor management and audit programs within Sarepta's biopharma operations. Responsibilities include conducting GPV and GLP/GCLP audits of approved vendors, developing audit plans, assessing vendor compliance, and supporting GxP inspections. The role also involves reviewing vendor responses, maintaining audit documentation, revising quality procedures, and ensuring adherence to global regulatory standards (FDA, ICH, OECD). Requirements: Bachelor’s degree in Life Sciences, 8+ years in pharmaceutical/biotech drug development, with at least 5 years in GxP auditing (external/internal). Expertise in OECD GLP, GPV, ICH GCP guidelines, FDA, and EU regulations is essential. Preferred: advanced degree, extensive audit experience, strong interpersonal skills, and ability to manage vendor compliance risks. High-value: focus on vendor oversight, GxP compliance, supporting quality systems, and facilitating regulatory inspections. Work setup: hybrid, with domestic and international travel (~20%).