Quality Assurance Manager

Job Summary

A company is looking for a Senior Manager, Quality Assurance.

Key Responsibilities

• Execute quality activities supporting patient support program processes and ensure compliance with standards
• Participate in the maintenance and execution of the Quality Management System (QMS) and author quality-related documentation
• Provide quality oversight for pharmacovigilance activities and support compliance with regulatory requirements

Required Qualifications

• Bachelor's degree in healthcare, life sciences, business, or a related field
• 6-8+ years of experience in quality assurance, compliance, or patient support program operations
• Direct experience supporting pharma-sponsored patient support programs
• Strong knowledge of HIPAA, privacy regulations, and FDA post-marketing requirements
• Hands-on experience with SOP execution and documentation review