GxP Document Control and Quality Systems Manager

Position Overview

Bicara Therapeutics is seeking 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, formatting, routing, review, approval, issuance, revision, archival, and retirement of controlled documents (SOPs, forms, templates, logs) in accordance with company procedures and applicable GxP requirements.

• As part of Document Control processing, critically read document content to ensure quality standards are met, including:

  • Ensuring details within different sections of the same document are accurate, consistent and aligned with content standards.

  • Ensuring details are accurate, aligned, and consistent across related documents (i.e. SOP and Forms).

  • Holding authors accountable to established document content and processing standards; able to clearly articulate what must be done and why.

• Serve as an internal trainer/coach, teaching authors and reviewers best practices for writing clear, compliant, and usable SOPs.

• Be a resource for form design for clear, efficient, and accurate data capture.

• Support authors in driving timely comment resolution; for example, scheduling live review sessions and editing documents on-screen in real time with the team to reach consensus efficiently.

• Manage periods of high document volume, including:

  • Prioritizing based on business need and risk.

  • Applying project management skills to ensure related groups of documents move through the process together and in line with established due dates.