Senior Manager, QA Compliance

Sarepta Therapeutics seeks a Senior Manager of QA Compliance to oversee GxP quality systems, manage product complaints and recalls, and drive continuous improvement across manufacturing and testing operations. The role requires extensive regulatory knowledge and cross-functional collaboration to ensure compliance with US and EU requirements.

Responsibilities

• Track, manage, and complete quality records including deviations, investigations, complaints, and CAPAs across functional areas
• Maintain quality metrics and KPIs; conduct quarterly and annual trending analyses to identify adverse trends and drive improvements
• Oversee product recall process, manage recalls, and execute annual mock recall exercises
• Ensure quality risk management processes comply with regulatory requirements and support risk assessments across departments
• Author and review GMP controlled documents including quality policies, procedures, and the quality manual

Requirements

• B.S. or B.A. in Life Science, Health Science, or Biology with 10+ years pharmaceutical/biopharmaceutical industry experience
• 5+ years hands-on QA or Quality Engineering experience with increasing responsibility
• Significant GMP experience with commercial products in global environments
• Extensive knowledge of US GxP regulations, EU GMP requirements, and industry practices
• Experience managing product complaints and recalls in commercial settings
• Proficiency with Veeva GMP Quality Management System
• US FDA or EU inspection experience; excellent written and verbal communication skills