Associate Director, GCP/GLP/GVP QA

Oversee GCP activities and quality execution for clinical studies by managing cross-functional relationships with internal and external stakeholders. Provide GCP oversight to functional groups, draft and review SOPs for regulatory compliance, and maintain the Quality Management System including audits, CAPAs, and training matrices. Proactively identify compliance risks, lead health authority inspections, and facilitate vendor and site audit processes. Review key safety and regulatory documents such as protocols, CSRs, and INDs while developing and delivering GCP training programs. Escalate systemic problems and recommend solutions to ensure consistent quality across clinical programs. This role reports to the Executive Director, Head of GCP/GVP/GLP QA, with a hybrid schedule based in Boston, MA, and requires up to 25% travel.