--- title: 'Sr. Quality Specialist, GxP Document Control at Bicara Therapeutics' canonical: 'https://feeny.ai/job/sr-quality-specialist-gxp-document-control-bicara-therapeutics-boston-pmtejzsn39sj' type: 'job' last_seen: '2026-09-13' --- # Sr. Quality Specialist, GxP Document Control at Bicara Therapeutics - **Company:** Bicara Therapeutics - **Location:** Boston, MA - **Compensation:** $105k–$128k - **Employment:** full-time - **Work type:** hybrid - **Posted:** 2026-06-26 - **Last confirmed live:** 2026-09-13 - **Apply:** https://jobs.ashbyhq.com/bicara-therapeutics/9fc4c470-0759-4661-990b-bd01b3c774da/application **Skills:** GxP, GCP, GMP, Document Control, Electronic Quality Management Systems (eQMS), Microsoft Excel, Smartsheet, Quality Metrics Reporting, CAPA Support, Change Control, Audit Scheduling, Clinical-stage biotechnology experience, Pharmaceutical experience > The Senior QA Specialist supports the administration and continuous improvement of the Quality Management System (QMS) at Bicara Therapeutics. Responsibilities include managing document control, audit scheduling, CAPA support, and quality metrics reporting to ensure compliance with GxP requirements. ## Job description 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). ## 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](http://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. ## About Bicara Therapeutics ## Company Overview - **One-liner**: Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class bifunctional antibodies that combine tumor-targeting with tumor microenvironment modulation, with a lead asset in head and neck squamous cell carcinoma. - **Entity Type**: Public (NASDAQ: BCAX) - **Headquarters**: Boston, Massachusetts, USA - **Founded**: 2020 - **Founders**: Not publicly listed ## Core Business - **Industry**: Biotechnology – oncology drug development - **Target Customers**: B2B (pharma partnerships, licensing) and ultimately cancer patients and healthcare providers - **Mission**: "Dedicated to improving the lives of people living with cancer through the development of innovative targeted therapies… bringing hope and control back into their lives." [bicara.com](https://www.bicara.com/) ## Products & Services - **[Ficerafusp alfa (BCA101)](https://www.bicara.com/)**: First-in-class, dual-action bifunctional antibody targeting EGFR and containing a TGF-β ligand trap. Currently in Phase 1/1b clinical development for HPV-negative head and neck squamous cell carcinoma and other solid tumors. Mechanism designed to deliver an immunomodulatory payload directly to the tumor microenvironment, reduce fibrosis/immunosuppression, and enable immune cell penetration. (Biologic, clinical-stage therapeutic) ## Market Standing - **Valuation/Market Cap**: ~$1.3 billion (as of mid-2026) [linkedin.com](https://www.linkedin.com/company/bicara-therapeutics) - **Key Metric**: Total funding raised $825M (includes Series C $165M led by The Rise Fund and TPG, $362M from 2024 IPO, and a $150M post-IPO equity round in February 2026) [linkedin.com](https://www.linkedin.com/company/bicara-therapeutics) - **Notable Investors/Partners**: The Rise Fund, TPG, Biocon (seed round). Additional institutional investors from IPO and follow-on offerings. - **Growth Signals**: IPO completed September 2024; headcount grew 78.1% year-over-year (95 employees, though LinkedIn notes a slight monthly decline of -0.9%); operates across 8 countries including the UK, Italy, Germany, India, and Spain; 11 active job postings as of mid-2026. [linkedin.com](https://www.linkedin.com/company/bicara-therapeutics) ## Competitive Advantages - **First-in-class bifunctional approach**: By combining an EGFR-targeting antibody with a TGF-β trap, BCA101 directly addresses a key solid-tumor resistance mechanism (TGF-β-driven immunosuppression and fibrosis) while localizing therapy to the tumor. - **Potential for superior efficacy and safety**: Designed to deliver synergistic therapeutic impact at the tumor site, aiming for deep, durable responses with reduced systemic toxicity. - **Experienced leadership**: Team with deep oncology drug development backgrounds and relationships with top cancer centers. [bicara.com/about](https://www.bicara.com/about/) ## Strategic Focus - **Priority**: Advancing ficerafusp alfa through clinical development toward potential regulatory approvals, initially in HPV-negative head and neck squamous cell carcinoma. - **Pipeline expansion**: Leveraging the bifunctional antibody platform (BCA101 and follow-on programs) to address multiple solid tumor types. - **Commercial readiness**: Hiring senior roles in medical affairs, quality, regulatory, and commercial operations signals preparation for launch. [bicara.com/careers](https://www.bicara.com/careers/) ## Why Work Here - **Culture & Mission**: A patient-first, mission-driven environment focused on developing meaningful new therapies for cancer. Company describes itself as "dynamic" with a shared passion for advancing science. [bicara.com](https://www.bicara.com/) - **Diversity & Inclusion**: Explicitly states commitment to building diverse teams and encourages applicants from all backgrounds. [bicara.com/careers](https://www.bicara.com/careers/) - **Growth Trajectory**: Fast-growing public company (78% headcount growth YoY) with a strong balance sheet, offering career progression opportunities. - **Work Environment**: Headquarters in Boston with a global presence. Specific remote/hybrid policy not publicly detailed, but the company employs staff across 8 countries. Glassdoor rating of 4.0/5 on LinkedIn based on limited reviews. [linkedin.com](https://www.linkedin.com/company/bicara-therapeutics) - **Engagement**: Active hiring across multiple senior-level roles in medical affairs, regulatory, quality, IT, and clinical operations, indicating a ramp-up toward commercialization. [bicara.com/careers](https://www.bicara.com/careers/) ## Sources 1. [bicara.com](https://www.bicara.com/) – Company home page, product, mission 2. [bicara.com/about](https://www.bicara.com/about/) – Leadership team, technology description 3. [bicara.com/careers](https://www.bicara.com/careers/) – Open positions, culture, diversity statement 4. [linkedin.com/company/bicara-therapeutics](https://www.linkedin.com/company/bicara-therapeutics) – Headcount, financials, stock info, employee reviews, talent sources 5. [massbio.org/members/bicara-therapeutics](https://www.massbio.org/members/bicara-therapeutics/) – Membership description, pipeline summary ## Other roles at Bicara Therapeutics - [Senior Manager, GxP Audit Program Lead](https://feeny.ai/job/senior-manager-gxp-audit-program-lead-bicara-therapeutics-boston-z2743dyfw8v5) — Boston, MA - [Director, Biostatistics](https://feeny.ai/job/director-biostatistics-bicara-therapeutics-boston-8acrty1k88h7) — Boston, MA - [Director, Marketing Operations](https://feeny.ai/job/director-marketing-operations-bicara-therapeutics-boston-308n8g5t9f73) — Boston, MA - [Senior Medical Science Liaison - West (CA, WA)](https://feeny.ai/job/senior-medical-science-liaison-west-ca-wa-bicara-therapeutics-united-states-tv5xs4prg9y2) — United States - [Associate Director, Financial Planning & Analysis (Development Finance Business Partner)](https://feeny.ai/job/associate-director-financial-planning-analysis-development-finance-business-nt8nz0xbxns1) — Boston, MA - [Senior Manager, Accounting and SEC Reporting](https://feeny.ai/job/senior-manager-accounting-and-sec-reporting-bicara-therapeutics-boston-hngf1v66tht9) — Boston, MA - [Associate Director, Global Scientific Communications](https://feeny.ai/job/associate-director-global-scientific-communications-bicara-therapeutics-boston-b20sj17zmqbw) — Boston, MA - [Senior Clinical Trial Manager](https://feeny.ai/job/senior-clinical-trial-manager-bicara-therapeutics-boston-07s96d5xygx4) — Boston, MA - [Associate Director, Project Management (Clinical Operations)](https://feeny.ai/job/associate-director-project-management-clinical-operations-bicara-therapeutics-jc50anna3jrm) — United States - [Senior Director, Regulatory Affairs](https://feeny.ai/job/senior-director-regulatory-affairs-bicara-therapeutics-boston-t7b77r839mdy) — Boston, MA