Sr. Quality Specialist, GxP Document Control

Bicara Therapeutics; Boston; On-site; PHP 5,518,087 - 7,357,449; Full time

Job summary

Bicara Therapeutics is hiring a Senior QA Specialist focused on GxP Document Control and Quality Systems, based in Boston with a hybrid schedule. This position is pivotal in supporting Quality Management System administration, ensuring compliance, and enhancing documentation practices.

The ideal candidate will have a scientific background, at least 5 years of Quality Assurance experience, and proficiency in Microsoft Excel and eQMS tools. This role includes working closely with other departments to ensure quality systems initiatives are successfully implemented.

Qualifications

• Minimum 5+ years of experience in Quality Assurance, Quality Systems, or Document Control.
• Experience within GxP-regulated environments.
• Strong proficiency in Microsoft Excel.

Responsibilities

• Lead document control activities within the electronic QMS.
• Maintain GxP documentation ensuring it’s inspection-ready.
• Support internal and external audit scheduling.

Skills

Quality Assurance

Document Control

GxP Regulatory Knowledge

Microsoft Excel

Analytical Skills

Organizational Skills

Communication Skills

Education

Bachelor’s degree in a scientific discipline

Tools

Smartsheet

Electronic Quality Management Systems (eQMS)

Job description

Position Overview

Reporting to the Sr. Director, GxP Quality Management Systems, the Senior QA Specialist, GxP Document Control and Quality Systems is responsible for supporting the administration, organization, and continuous improvement of the Quality Management System (QMS) at Bicara Therapeutics. 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.

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.