Associate Director, GCP Compliance

Role: Associate Director, GCP Compliance, leading the design and continuous improvement of a risk-based Quality Management System (QMS) aligned with ICH GCP E6(R3). Responsibilities include overseeing controlled documentation, vendor quality, TMF health, training programs, change control, deviations, CAPAs, and inspection readiness; managing GxP-compliant systems; and fostering a culture of quality. Qualifications: Bachelor's in a scientific discipline, 5–7 years in GxP quality or compliance roles with at least 2 years in leadership or document control; proven expertise in GCP (risk-based quality management, vendor oversight); experience with TMF, CAPA systems, and inspection readiness; strong understanding of GCP/GMP interface and regulatory expectations; biotech or startup experience preferred. High-Value: Focus on GCP compliance within a cell therapy biotech developing anti-autoimmune therapies, including fully human CD19-CAR T cells; involvement in clinical development programs; working with CROs; supporting regulatory inspections. Work setup: Remote, hybrid, or Philadelphia HQ; no travel specified.