Manager, GxP Document Control and Quality Systems

Position Overview

Bicara Therapeutics is seeing a Manager, GxP Document Control who will manage and continuously improve document control operations and quality systems coordination for Bicara Therapeutics. Reporting to the Sr. Director, GxP Quality Management Systems, this role is expected to critically read and evaluate procedural content, ensure consistency and technical accuracy within and across controlled documents, and coach authors and reviewers on writing clear, followable, audit-ready procedures. The Manager will lead cross-functional teams through a high-volume, dynamic period of document generation, balancing speed, accuracy, fit-for-purpose judgment, and compliance. The role also provides general quality systems function support, including GxP Training program administration, vendor and clinical site audit coordination, and serves as a flexible, go-to resource across the Quality organization.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

Document Control & SOP Content Quality

• Lead day-to-day document control activities within the electronic QMS, including template and document development, formatt