Product Quality Lead

📋 Description

• Lead cross-functional product quality activities across lifecycle.
• Act as main quality contact for development strategy and global supply.
• Ensure end-to-end compliance from clinical to commercialization.
• Support product transitions, tech transfers, and lifecycle management.
• Coordinate QA activities across markets (e.g., launches) and audits.
• Hybrid role requiring on-site presence in Morrisville, NC or San Diego, CA.

🎯 Requirements

• High-level education in pharmaceutical, biotech, or life sciences
• 10+ years in pharmaceutical and biotech products under GMP
• Proven experience transitioning development projects to future commercial setup
• Strong leadership with a proven track record with Health Authorities
• Deep understanding of GMP & GDP requirements and strategic planning
• Fluent in English with excellent communication and interpersonal skills

🎁 Benefits

• Generous time off policy
• Opportunity to attend popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients