Vice President, Quality

Position overview

Bicara Therapeutics is hiring a Vice President of Quality to join the leadership team and help guide the company’s long-term growth, readiness for regulation, and operational discipline. This person will need to think strategically while also staying close to execution, creating a Quality organization that can grow with the business and safeguard product integrity, patient safety, and compliance. A major part of the role is to define and communicate an end-to-end Quality strategy that supports the transition from clinical development into commercial manufacturing.

As the senior leader accountable for Quality, this role shapes the company’s quality vision, culture, and systems. Reporting to the Chief Development Officer, the VP will influence how the company delivers important therapies to patients while establishing the strategic and operational base for a strong quality infrastructure. The role is based in Boston, MA and follows a hybrid arrangement with three in-office days per week.

Enterprise quality strategy and leadership

• Build a company-wide mindset centered on quality, ownership, and ongoing improvement.
• Serve as a highly visible leader who sets the standard and reinforces that quality is a responsibility shared across all functions.
• Create and communicate a comprehensive Quality strategy that aligns with company goals and supports the move from clinical development to commercial operations.
• Look ahead to regulatory, operational, and market demands so the Quality organization is designed to meet future needs.
• Establish a risk-based Quality framework that supports innovation without compromising compliance.

Clinical and commercial quality leadership

• Bring deep experience across clinical GCP and commercial GMP environments, including late-stage development, technology transfer, scale-up, supply chain quality, batch release, QP requirements, and post-market obligations with global partners.
• Be willing to step directly into important investigations, decisions, and issue resolution in a lean organization.
• Maintain exceptional attention to detail and the ability to work through technical matters when necessary.
• Understand global regulatory expectations for commercial biologic products.

External partner oversight

• Manage CMOs, CROs, and other vendors through clear governance, audits, and performance tracking.
• Handle complex external manufacturing networks effectively.
• Lead regulatory inspections successfully and with confidence.
• Stay ahead of agency expectations, close identified gaps, and keep the organization continuously inspection-ready.

Operational excellence and systems oversight

• Own the design, approval, and ongoing effectiveness of quality systems, working closely with IT.
• Oversee core quality operations such as batch disposition, deviation and investigation management, supplier quality, QP release, and document control.
• Develop and implement quality processes, systems, and performance measures suited to a rapidly growing organization with ambitious clinical plans and future commercialization goals across multiple oncology indications.
• Work closely with Regulatory, Technical Operations, Supply Chain, Clinical Operations, Commercial, Finance, IT, and Legal to ensure alignment with applicable local and global requirements, including GxP and regional distribution obligations.

Team building and organizational development

• Build and lead a high-performing Quality Assurance organization.
• Develop scalable teams, mentor employees, and encourage strong cross-functional collaboration.

Financial stewardship

• Manage Quality budgets across relevant functions and align them with company development plans.
• Partner with Finance on long-range planning and scenario modeling.

Qualifications

The ideal candidate should hold a bachelor’s degree in life sciences, chemistry, engineering, or a related field, with an advanced degree such as an MBA or MS strongly preferred. The role calls for 15+ years of progressive experience in quality organizations and a strong track record of building and leading quality teams in pre-commercial and early commercial settings, including domestic and international launch experience.

Applicants should bring extensive knowledge of quality systems, inspections, audits, and applicable FDA and EMA regulations, along with experience managing regulatory inspections in both clinical and commercial environments. Prior success working with CMOs and CROs, overseeing vendor relationships, applying KPI-based governance, and supporting technology transfer, batch release, stability, and PPQ is preferred.

This position also requires the ability to operate at both strategic and hands-on levels in fast-changing environments, strong financial acumen, experience managing multimillion-dollar budgets and COGS optimization, and a history of effective communication with executive leadership and boards. The right leader will be decisive, risk-aware, collaborative, transparent, passionate about developing talent, and committed to building durable organizations.

Company overview

Bicara Therapeutics is a clinical-stage biotechnology company focused on bifunctional antibodies for targeted tumor modulation. Founded in 2020, the company has a global workforce of more than 100 employees and is based 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 approach is intended to localize to the tumor while also modulating the tumor environment to improve efficacy, safety, and durability of response. The program is aimed at helping immune cells penetrate tumors, reducing fibrosis and immunosuppression, and countering TGF-β-driven resistance mechanisms to support deeper and longer-lasting patient responses.

Culture and equal opportunity

The company values diverse teams and an inclusive environment where all voices are welcomed. Candidates from all backgrounds are encouraged to apply. Bicara Therapeutics 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 status protected by federal, state, or local law.

Compensation

The compensation range for this role is $315,000 to $371,000.