Senior Director of Product Quality

Job Summary

A company is looking for a Senior Director, Product Quality.

Key Responsibilities

• Provide strategic and technical leadership to ensure product quality across late-phase clinical and commercial programs
• Advise on CMC strategies and quality risk management for commercialization and lifecycle management
• Collaborate with cross-functional leaders to resolve issues and drive continuous improvement in quality processes

Required Qualifications

• Doctorate degree with 5 years of relevant experience, or a Master's degree with 9 years, or a Bachelor's degree with 11 years of experience in CMC Regulatory, Quality, Operations, Scientific, or Manufacturing
• At least 5 years of experience managing people or leading teams and projects
• Advanced degree in a related biotechnology sciences field is preferred
• Expertise in protein and small molecule analysis and industry regulations
• Experience working in a regulated environment with knowledge of cGMP and regulatory requirements