Associate Director, Quality

 The Role:

The Associate Director of Quality is responsible for managing quality assurance activities, providing strategic oversight of the implementation of a Quality Management System (QMS), and ensuring compliance with FDA, ICH, and other regulatory standards. This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) across our CROs. The successful candidate will establish quality frameworks from the ground up and lead quality initiatives that support the company's pipeline from preclinical research through clinical development in a fast-paced, resource-conscious environment. The Associate Director, Quality reports to the Vice President, Head of Regulatory and Quality. This is a full-time hybrid role.

What You Will Do:

Quality Program Development 

• Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP )
• Implement pragmatic quality approaches that balance compliance with operational efficiency
• Create quality culture and awareness across all organizational levels
• Excellent leadership, communication, and interpersonal skills

CRO Management & Strategic Partners