Vice President, Quality

Position Overview

Bicara Therapeutics is seeking a Vice President, Quality to serve as a key member of the leadership team, playing a critical role in shaping the company’s long‑term success, regulatory readiness, and operational excellence. This leader must operate as both a strategic architect and a hands‑on leader, capable of building a robust Quality function that scales with the organization’s growth and ensures product integrity, patient safety, and compliance by developing and communicating a holistic Quality strategy that supports the shift from clinical development to commercial manufacturing.

The VP, Quality serves as the chief steward of the company’s quality vision, culture, and systems. Reporting to the Chief Development Officer, this leader will directly shape the company’s ability to deliver life‑saving medicines to patients in need, while laying both strategic and operational foundations for a quality infrastructure.

This role is based in our Boston office and follows a hybrid schedule, with three in‑office days each week.

Enterprise Quality Strategy & Leadership

• Embedding a company‑wide culture of quality, accountability, and continuous improvement.
• Acting as a visible, influential leader who models high standards and reinforces quality as a shared responsibility across functions.
• Developing and communicating a holistic Quality strategy that supports the shift from clinical development to commercial that is aligned with the company’s goals.
• Anticipating future regulatory, operational, and market needs and ensuring the Quality function is structured to meet them.
• Building a proactive, risk‑based Quality framework that balances innovation with compliance.

Strong Clinical & Commercial Quality Expertise

• Deep experience with clinical GCP & commercial GMP operations, including late‑stage development, tech transfer, scale‑up, supply chain quality, lot release, QP requirements and post‑market requirements with global partners.
• Willingness to engage directly in critical tasks, investigations, and decisions—especially in a small, resource‑lean environment.
• Meticulous attention to detail with the ability to dive into technical issues when needed.
• Knowledge of global regulatory frameworks and expectations for commercial biologics products.

External Partner Ecosystem

• Ensuring effective oversight of CMOs, CROs, and vendors through structured governance, auditing, and performance monitoring.
• Experience managing complex external manufacturing networks.
• Proven track record leading successful regulatory inspections.
• Ability to anticipate agency expectations, remediate gaps, and maintain a continuous state of inspection readiness.

Operational Excellence and Oversight

• Accountability for the design, approval, and ongoing health of the company’s quality systems in collaboration with IT.
• Oversight of quality operations, including batch disposition, deviation/investigation management, supplier quality, QP release, and document control.
• Develop and implement quality processes, systems, and performance metrics as appropriate for a fast‑growing organization with aggressive clinical development plans and future commercialization vision across potentially multiple indications in oncology.
• Partner closely with Regulatory, Technical Operations, Supply Chain, Clinical Operations, Commercial, Finance, IT, and Legal to ensure full alignment and compliance with relevant local and global regulatory requirements, including GxP and any local regional distribution requirements.

Team Building & Organizational Development

• Ability to build, inspire, and lead a high‑performing QA organization.
• Skill in developing scalable teams, mentoring talent, and fostering cross‑functional collaboration.

Financial Stewardship

• Own and manage Quality budgets across relevant functions and in alignment with CDPs.
• Partner with Finance to support LRP scenario modeling.

• Bachelor’s degree in life sciences, chemistry, engineering, or related discipline. Advanced degree (MBA or MS) strongly preferred.
• 15+ years of progressive industry experience in quality organizations.
• Demonstrated success in building and leading quality organizations in…