Manager/Senior Manager, QA Operations

📋 Description

• Support the development and implementation of corporate quality management systems
• Partner with Quality Systems and Compliance teams to promote continuous improvement
• Develop and monitor key performance indicators (KPIs) to evaluate CMO performance
• Oversee QA Operations activities including review and approval of GMP documentation
• Identify and resolve compliance gaps ensuring inspection readiness
• Act as primary quality liaison between organization and external suppliers

🎯 Requirements

• Bachelor of Science degree preferred in scientific discipline
• At least six years in pharmaceutical Quality Assurance with three years managing contract operations
• At least one year managing or supervising QA team preferred
• Experience with CDMOs and managing external partner relationships preferred
• Strong practical knowledge of API and drug product manufacturing processes
• Comprehensive understanding of FDA, EEA, Health Canada regulations, ISO standards

🎁 Benefits

• Salary range: $125,000–$140,000
• Annual bonus opportunity
• Significant equity compensation
• Competitive employee benefits package
• Hybrid work arrangement with three on-site days per week in New York City