GCP & GLP QA Lead (Nonclinical & Clinical Quality Assurance)

Role: Lead GCP and GLP quality assurance for clinical and nonclinical programs at Tango Therapeutics, supporting regulatory compliance and inspection readiness. Responsibilities: define and implement risk-based audit strategies across CROs, vendors, and laboratory sites; oversee GCP/GLP study audits, documentation, and CAPA processes; lead inspection preparations and responses; ensure SOPs and training are current; provide QA guidance to clinical and nonclinical teams; manage vendor relationships and oversight of outsourced studies. Requirements: Bachelor’s in Life Sciences; 8-12 years in GLP/GCP QA, with experience supporting FDA BIMO inspections; strong knowledge of ICH guidelines, GLP regulations, and vendor oversight. Preferred: advanced degree or formal training in clinical research or quality; GCP/GLP auditor certification; expertise in data integrity and inspection management. HighValue: GCP/GLP audit strategy, vendor oversight, inspection readiness, regulatory compliance, clinical and nonclinical audit execution, FDA BIMO experience, biopharma quality systems. WorkSetup: not specified; likely hybrid or onsite in Boston.