Manager, GxP Document Control and Quality Systems at bicara-therapeutics

Bicara Therapeutics is hiring a Manager, GxP Document Control to lead document control operations and quality systems coordination in its electronic QMS. The role manages SOPs, forms, templates, logs, reviews, approvals, revisions, archival, and retirement; coaches authors and reviewers; supports training administration, vendor and clinical-site audit coordination, GxP record filing, gap assessments, and inspection readiness. It is based in the Boston office on a hybrid schedule with three in-office days per week and requires a bachelor's degree in a scientific discipline or equivalent experience, plus at least five years of Quality Assurance or Quality Systems experience, including three years in Document Control within a regulated industry.