Vice President, Quality

Position Overview

Bicara Therapeutics is looking for a Vice President of Quality to join the leadership team and play a central role in strengthening regulatory preparedness, operational effectiveness, and the company’s future growth. This person will need to think strategically while also staying close to the work, helping build a Quality organization that can expand with the business and protect product integrity, patient safety, and compliance. A major part of the role is to create and clearly communicate a comprehensive Quality strategy that supports the move from clinical development into commercial manufacturing.

As the senior owner of the company’s Quality vision, culture, and systems, this leader will report to the Chief Development Officer and help establish the quality foundation that supports the delivery of important medicines to patients. The position is based in Boston and follows a hybrid model with three days per week in the office.

Enterprise Quality Strategy and Leadership

• Promote a company-wide mindset of quality, accountability, and ongoing improvement.
• Serve as a highly visible leader who sets the tone for high standards and reinforces quality as a shared responsibility across the business.
• Create and communicate an integrated Quality strategy that aligns with company priorities and supports the transition from clinical development to commercial operations.
• Stay ahead of future regulatory, operational, and market requirements so the Quality function is prepared for what comes next.
• Establish a risk-based Quality framework that supports innovation while maintaining compliance.

Clinical and Commercial Quality Expertise

• Bring strong experience across clinical GCP and commercial GMP environments, including late-stage development, technology transfer, scale-up, supply chain quality, lot release, QP requirements, and post-market obligations with global partners.
• Be willing to step directly into important technical work, investigations, and decisions, particularly in a lean organization.
• Show strong attention to detail and the ability to investigate technical issues deeply when needed.
• Understand global regulatory expectations for commercial biologics.

External Partner Oversight

• Provide effective governance for CMOs, CROs, and vendors through structured oversight, audits, and performance tracking.
• Have experience managing complex external manufacturing networks.
• Demonstrate success leading regulatory inspections.
• Anticipate agency expectations, close quality gaps, and maintain a constant state of inspection readiness.

Operational Excellence and Oversight

• Own the design, approval, and continued effectiveness of the company’s Quality systems in partnership with IT.
• Oversee quality operations such as batch disposition, deviation and investigation management, supplier quality, QP release, and document control.
• Develop and implement processes, systems, and performance metrics suited to a fast-growing company with ambitious clinical programs and future commercialization plans across multiple oncology indications.
• Work closely with Regulatory, Technical Operations, Supply Chain, Clinical Operations, Commercial, Finance, IT, and Legal to ensure alignment with local and global requirements, including GxP and regional distribution obligations.

Team Building and Organizational Development

• Build, motivate, and lead a high-performing Quality Assurance organization.
• Develop scalable teams, mentor talent, and encourage strong collaboration across functions.

Financial Stewardship

• Manage Quality budgets across relevant areas in line with the company development plan.
• Partner with Finance to support long-range planning and scenario modeling.

Qualifications

The role calls for a bachelor’s degree in life sciences, chemistry, engineering, or a related field; an MBA or MS is strongly preferred. Candidates should have at least 15 years of progressive industry experience in Quality organizations, along with a history of building and leading quality teams in pre-commercial and early commercial settings, including domestic and international launch experience.

Strong regulatory knowledge is required, including Quality systems, inspections, audits, and applicable FDA and EMA regulations. Experience leading regulatory inspections in both clinical and commercial environments is preferred. The company is also looking for someone who has managed external partners such as CMOs and CROs, handled complex vendor relationships strategically, and implemented meaningful KPI systems and accountability measures. Background in technology transfer, batch release, stability, and PPQ is preferred.

Success in this role also requires the ability to operate effectively at both strategic and operational levels in ambiguous, fast-moving settings. Candidates should bring strong financial acumen, including experience managing multimillion-dollar budgets and optimizing cost of goods. Effective executive- and board-level communication, influence, and cross-functional leadership are important, along with sound judgment, risk awareness, and a Quality-first mindset. The ideal person is collaborative, transparent, committed to talent development, and focused on building durable organizations.

Company Overview

Bicara Therapeutics is a clinical-stage biotechnology company developing bifunctional antibodies for targeted tumor modulation. Established in 2020, the company has more than 100 employees worldwide and is headquartered in Boston. Its lead program, ficerafusp alfa (FICERA), is designed as a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap.

The company’s approach combines tumor targeting with tumor modulation, using one arm to localize to the tumor and the other to modulate the environment. The goal is to improve efficacy, safety, and durability directly at the tumor site. FICERA is intended to address major challenges in solid tumor treatment by helping immune cells penetrate tumors, reducing fibrosis and immunosuppression, and countering TGF-β-driven resistance mechanisms to support deep and durable responses that may improve patient outcomes and survival.

Culture and Equal Opportunity

Bicara Therapeutics values diverse teams and aims to build an environment where every voice is heard. The company welcomes candidates from all backgrounds. It is an equal opportunity employer and does not discriminate on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any other classification protected by applicable law.

Compensation

The stated compensation range is $315K to $371K.