Director, Product Development Quality

📋 Description

• Lead development-stage quality operations for pharmaceutical and radiopharmaceutical programs.
• Establish quality frameworks and influence regulatory readiness globally.
• Partner with cross-functional teams to implement fit-for-purpose quality strategies.
• Support clinical supply activities, including manufacturing, packaging, labeling, and release
• Input for regulatory submissions (IND/CTA, CTD Module 3) and development program documentation.
• Mentor and develop Quality team members and drive continuous improvement.

🎯 Requirements

• Advanced degree (MS, PharmD, PhD) preferred; equivalent experience considered.
• 10+ years of progressive quality experience in pharma/biotech/radiopharmaceuticals.
• 7+ years leading and scaling quality teams with development-stage GMP exposure.
• Direct radiopharmaceutical quality experience (short half-life manufacturing, real-time release
• Experience with IND/CTA, NDA/BLA quality strategies, CTD Module 3.
• Strong GMP knowledge, risk management, regulatory expectations, and cross-functional collaboration.

🎁 Benefits

• Competitive salary with performance-based bonus opportunities.
• Equity-based incentives; remote and flexible work environment.
• Generous vacation and wellness days; professional development support.
• Opportunity to contribute to precision medicine programs with global impact.
• Collaborative, international team focused on improving patient outcomes.