Sr. Quality Specialist, GxP Document Control

Position Overview

Bicara Therapeutics is seeking a Senior QA Specialist, GxP Document Control and Quality Systems to support the administration, organization, and continuous improvement of the Quality Management System (QMS). This role reports to the Sr. Director, GxP Quality Management Systems. This role serves as a key resource for document control, quality systems coordination, audit scheduling and tracking, and general QA operational support. Core to this work is ensuring quality documentation is accurate, organized, inspection-ready, and maintained in accordance with company procedures and applicable GxP requirements.

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

Responsibilities

• Lead day-to-day document control activities within the electronic QMS, including 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.

• Organize, maintain, and archive GxP documentation that exists outside the formal QMS structure, ensuring it’s inspection-ready and easily retrievable.

• Serve as a key operational support resource for the GxP QMS function, partnering closely with the GMP Operations & Supplier Management and Clinical GCP Quality teams to support quality systems activities across the organization.

• Develop and maintain training curriculum and GxP tracking, support administration of Deviation/CAPA support, Change Control, Management Review processes and inspection readiness.

• Support internal and external audit scheduling and logistics, track audit status, and assist with follow-up activities as needed to support Director, GxP Auditing.

• Develop and maintain quality metrics, dashboards, trackers, and trending tools (including Smartsheet and Microsoft Excel) to support QA operational oversight, compliance monitoring, management review, and continuous improvement initiatives.

• Collaborate cross-functionally with Quality and other departments (internally and externally) to support ongoing quality systems improvements and ensure compliance with applicable GxP requirements, including GCP and GMP activities.

• Support additional Quality Systems initiatives and operational activities as assigned by the Senior Director, GxP Quality Management Systems.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent combination of education and relevant industry experience.

• Minimum 5+ years of experience in Quality Assurance, Quality Systems, or Document Control within the biotechnology, pharmaceutical, or other regulated industry.

• Experience working within GxP-regulated environments, including support of GCP and/or GMP quality systems activities.

• Working knowledge of document control processes and electronic Quality Management Systems (eQMS).

• Experience supporting quality systems activities such as audits, CAPAs, training management, controlled documentation, inspection readiness, and quality metrics reporting.

• Strong proficiency in Microsoft Excel and experience using Smartsheet or similar electronic tracking and reporting tools.

• Strong organizational, analytical, and problem-solving skills with the ability to manage multiple priorities and timelines in a fast-paced environment.

• Strong attention to detail with the ability to work both independently and collaboratively across functions.

• Excellent written and verbal communication skills.

• Experience in clinical-stage biotechnology or pharmaceutical environments preferred.

Company Overview

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.