Vice President, Quality
Job Description
Position Overview
The Vice President, Quality is a key member of the leadership team who plays 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.
Responsibilities
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 CDPs
Partner with Finance to support LRP scenario modeling
Qualifications
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 pre-commercial and early commercial environments with domestic and internal commercial launch experience
Extensive knowledge of regulatory requirements, Quality systems, inspections, audits, and all applicable FDA and EMA regulations
Experience in leading and managing regulatory inspections ideally including both clinical and commercial stage environments.
Deep expertise managing external partners (CMOs/CROs) and complex vendor relationships with a strategic view while successfully implementing appropriate KPI mechanisms and accountability. Experience with technology transfers, batch release, stability and PPQ preferred.
Proven ability to operate at both strategic and operational levels in fast growth, ambiguous environments
Strong financial acumen, including effective multimillion budgets and COGs optimization
Track record of effective executive and BOD level communication, influence, and cross functional leadership
Decisive, risk-aware leader with strong judgment and a Quality-first mindset
Collaborative, transparent communicator who builds trust across functions and with external partners
Passionate about talent development, succession planning, and building durable organizations
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.
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.