Biologics Quality Assurance Manager

Job Summary

A company is looking for a Senior Manager, Global Product Quality - Biologics.

Key Responsibilities

• Manage quality oversight of clinical and commercial biologics products at contract manufacturers to ensure compliance with GMP standards
• Conduct batch record reviews and release activities for investigational and commercial products
• Collaborate with internal teams and suppliers to support regulatory submissions and maintain quality metrics

Required Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or related Science
• Four years of experience in the pharmaceutical/medical device industry in a management role related to Manufacturing, QA, or QC
• Two to three years of experience managing CMOs/CDMOs or in auditing
• Proven experience with biologics GMP manufacturing processes
• Ability to travel domestically (20%) and occasionally internationally