Quality Assurance Manager

Job Summary

A company is looking for a Quality Assurance Manager.

Key Responsibilities

• Support and manage Quality Systems, including deviations, change control, and CAPA
• Maintain vendor management and assessment activities
• Act as QA point of contact on project teams, ensuring compliance with regulatory/GMP expectations

Required Qualifications and Education

• Bachelor's degree in a science-related field
• 10+ years of cGMP Quality experience
• Experience with risk assessment exercises
• Experience working with CDMOs as a client/sponsor preferred
• Working knowledge of FDA-regulated biotechnology or pharmaceutical industry standards