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

Role: Early Development Quality Lead overseeing quality assurance for nonclinical studies, IND enabling work, and biomarker utilization in biopharma development programs. Responsibilities: set strategic quality oversight for GLP and non-GLP studies, manage external lab/vendor performance, ensure compliance with GxP standards (GCP, GLP, ICH, OECD), conduct risk-based audits, address quality issues, and lead process improvements within the QMS. Qualifications: minimum 8 years of relevant experience in bioanalytical and toxicology sciences, with expertise in GLPs, GCPs, GCLPs, assay development, and validation; preferably with a master’s degree in life sciences or related field. High-Value: focus on nonclinical biomarker work, toxicology, GLP/GCP regulated environments, global regulatory compliance (FDA, EMA, PMDA), and risk-based vendor oversight. WorkSetup: hybrid, onsite, or remote within the US.