Director of Quality Assurance

Job Summary

To support the international roll-out of approved cancer imaging agents, the full-time salaried Director of Quality Assurance will oversee product quality and compliance within commercial manufacturing operations, ensuring adherence to regulatory standards and driving continuous improvement initiatives.

Key responsibilities:

• Manage and enhance quality management systems across intermediates, Bulk Drug or API, Drug Product, Packaging, and Labeling
• Collaborate with cross-functional teams to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements
• Lead strategic quality improvement initiatives and establish an analytical framework for quality problem-solving

Required qualifications:

• Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred
• 12+ years of experience in quality within the pharmaceutical or biotechnology industry
• 8+ years of leadership experience in the pharmaceutical or biotechnology sector
• Proven track record in driving continuous improvement of pharmaceutical quality systems
• Strong understanding of global regulatory requirements, including FDA and EMA regulations