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

Associate Director, Early Development Quality Lead, R&D QA Overview The Early Development Quality Lead is responsible for the strategicquality oversight of internal and external (outsourced) activities in support of nonclinical studies (GLP and non-GLP), IND enabling work, as well as the utilization of Biomarkers within development programs (preclinical and clinical). This role will partner with Alnylam colleagues within Early Development, Bioanalytical, Nonclinical Writing, Research, and Clinical Research to provide quality support and oversight and ensure the identification, mitigation, and escalation of emerging quality risks and concerns. This position will be located within the US and can be hybrid, onsite, or remote. Key Responsibilities Sets the strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical studies (GLP and non-GLP), including toxicology, bioanalytical and biomarker data that supports IND submissions. Establish and maintain quality oversight of external laboratories including Test Facilities, Test Sites, and Clinical Laboratories by implementing governance framework and ongoing performance monitoring. Collaborate with nonclinical and clinical teams (in partnership with GCP Program Leads) to integrate quality considerations into the selection, contracting, and management of external labs. Ensure internally developed and outsourced biomarker development / analytical work complies with internal quality s