Executive Director, CMC Quality Assurance - Remote

Overview

The Executive Director, CMC Quality Assurance will lead and build a comprehensive QA team to support the development, manufacturing, and regulatory approval of all Dianthus products.

In Short

• Lead and scale the QA team for drug and device development.
• Ensure compliance with global regulatory requirements.
• Oversee the Event and CAPA process.
• Support supplier and contract manufacturer audits.
• Guide technical development quality oversight.
• Represent QA during health authority inspections.
• Support regulatory submissions as QA lead.
• Collaborate cross-functionally with various teams.
• Drive continuous improvement initiatives.
• Some travel (approx. 20%) required.

Requirements

• BS or MS degree in life sciences or engineering required.
• Experience in biotech/pharma with combination product development.
• Progressive QA leadership experience in biotech/pharma.
• Deep knowledge of GMP regulations and device-specific standards.
• Broad knowledge of Quality Systems.
• Proven track record supporting drug development.
• Experience with autoinjector or similar products.
• Experience in risk management processes and tools.
• Strong leadership and communication skills.
• Results-oriented and flexible in thought.

Benefits

• Opportunity to impact combination product development.
• Join a rapidly growing organization.
• Work in a culture centered around core principles.
• Flexible remote working options.