Associate Director, Early Development Quality Lead, R&D QA

Role: Early Development Quality Lead responsible for strategic quality oversight of preclinical and clinical nonclinical studies, including GLP and non-GLP activities supporting IND enabling work and biomarker utilization. Responsibilities: establish and monitor quality governance of external labs and testing facilities, ensure compliance with GxP and regulatory standards (FDA, EMA, PMDA), manage quality issues and CAPAs, lead risk-based vendor oversight, and drive process improvements within the QMS. Qualifications: minimum 8 years in bioanalytical, toxicology, or related fields; experience with GLP, GCP, GCLP regulations; background in assay development/validation and biomarker assays (PCR, ELISA, FISH); degree in life sciences or equivalent. High-Value: focus on nonclinical studies, biomarker development, GLP/GCP expertise, global regulatory compliance, risk-based vendor oversight. Work Setup: hybrid, onsite, or remote within the US, with no specific travel expectations.