Associate Director Quality Lead

Job Summary

Focusing on strategic quality oversight for nonclinical studies, the full-time Associate Director Quality Lead will manage internal and outsourced laboratory activities, ensuring compliance with regulatory standards while working in a hybrid or remote capacity.

Key responsibilities

• Set strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical studies
• Establish and maintain quality oversight of external laboratories through governance frameworks and performance monitoring
• Collaborate with nonclinical and clinical teams to integrate quality considerations into the selection and management of external labs

Required qualifications

• Master's degree in a science, technology, or industry-related discipline preferred, or equivalent work experience
• Minimum of 8 years of relevant experience in bioanalytical and toxicology subject matter related to GLPs, GCPs, and GCLPs
• Direct experience in assay development and validation, with familiarity in modern biomarker-based assays preferred
• Prior experience in risk-based thinking, quality assurance, and managing quality issues
• Expertise in global GLP, GCP, and GCLP regulations across various regulatory bodies