Senior Director, GxP Quality Management Systems (QMS)

Position Overview

Bicara Therapeutics is seeking a Senior Director, Quality Management Systems (QMS), reporting to the VP, Global Quality, to build and lead the company’s QMS from the ground up. This hands‑on leadership role will establish a scalable, phase‑appropriate quality framework that supports all GxP activities while driving speed, operational efficiency, and sustained inspection readiness.

This role is based in Boston with a hybrid schedule (three days onsite per week); however, a remote schedule may be considered.

Responsibilities

QMS Leadership

• Design, implement, and continuously improve an integrated QMS to support all GxP activities at Bicara
• Partner with GMP and GCP Quality leads to build practical, fit‑for‑purpose processes
• Lead the establishment of QMS governance, driving consistent and effective use of quality systems across the organization
• Collaborate with IT, Quality leaders and other int...