Product Quality Director

Job Summary

Leading a cross-functional team, the full-time remote Product Quality Director will provide technical expertise and strategic leadership to ensure product quality and compliance throughout the product development lifecycle, focusing on regulatory submissions, stability programs, and process improvements.

Key Responsibilities

• Manage complex long-term deliverables for late-phase and commercial programs, ensuring quality compliance and oversight of product quality activities
• Provide scientific and risk-based evaluations of process and product quality data, developing patient-oriented strategies to address complex issues
• Mentor team members and communicate complex information effectively to leadership and regulatory agencies

Required Qualifications

• Doctorate degree and 4 years of relevant experience, or Master's degree and 7 years, or Bachelor's degree and 9 years in Quality, Operations, Scientific, or Manufacturing roles
• Advanced degree in chemistry, biochemistry, biology, or related biotechnology sciences preferred
• 8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, or regulatory environments
• 6+ years working in a regulated environment with direct GMP experience
• Experience in managing staff and leading cross-functional teams in a matrix environment