Senior Manager, GMP Quality Operations

Job Summary

A company is looking for a Senior Manager, GMP and QMS Quality Operations.

Key Responsibilities

• Provide operational quality oversight for manufacturing processes and support continuous improvement within QA operations
• Lead training initiatives and manage training compliance oversight
• Identify inefficiencies in Quality workflows and contribute to the development of SOPs and process improvements

Required Qualifications

• Bachelor's degree in life science or related discipline
• 7-10 years of experience in QA, QMS, QC, or Manufacturing in an FDA-regulated industry
• In-depth experience in clinical product development and commercialization
• Direct experience with regulatory submissions and inspections
• Proficiency in Veeva Quality Suite and experience with operational excellence methodologies