Director of Quality Assurance

Job Summary

To support the international roll-out of approved prostate cancer imaging agents, the full-time salaried Director of Quality Assurance will ensure the highest standards of product quality and compliance within commercial manufacturing operations, overseeing quality management systems and driving continuous improvement initiatives.

Key responsibilities:

• Oversee and enhance quality management systems, ensuring alignment with Good Manufacturing Practices (GMP) and regulatory compliance
• Lead strategic quality improvement initiatives and collaborate with cross-functional teams to address quality needs early in the product pipeline
• Ensure proper documentation practices and maintain regulatory compliance across all manufacturing processes and sites

Required qualifications:

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