Director of Quality Assurance

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