Director, Product Quality - Remote

Overview

This position is for a Director of Product Quality responsible for overseeing quality strategy and implementation in cutting-edge cell therapy programs, ensuring compliance with regulatory standards and alignment with business objectives.

In Short

• Lead end-to-end technical quality oversight for drug substance and drug product CMOs.
• Develop and implement comprehensive product quality strategies.
• Support regulatory submissions and serve as Quality lead for regulatory inquiries.
• Advise on commercialization strategies and lifecycle management.
• Conduct science- and risk-based evaluations of product and process data.
• Lead major investigations and change controls impacting product quality.
• Establish and manage the Product Quality Risk Management framework.
• Ensure timely execution of product quality activities.

Requirements

• Bachelor’s degree in Biology, Chemistry, Engineering, or related scientific discipline; advanced degree preferred.
• 10+ years of experience in pharmaceutical or biotechnology industry.
• Minimum 5 years in a Quality leadership role.
• Deep knowledge of cGMP and international regulatory expectations.
• Proven experience in technical transfers and commercialization oversight.
• Strong analytical and problem-solving skills.
• Excellent communication skills with regulatory submissions experience.
• Demonstrated ability to collaborate across teams.
• Experience with CDMOs preferred.
• Proficiency in MS Office suite.

Benefits

• Competitive salary range: $210,000–$226,000.
• Comprehensive health, dental, and vision insurance.
• 401(k) with company match and Flexible Spending Accounts.
• Generous paid time off and holidays.
• Opportunities to work remotely in approved U.S. states.
• Professional development opportunities.
• Collaborative and inclusive work environment.