Vice President, Quality

Bicara Therapeutics

Vice President of Quality leading quality initiatives for a biotech company focused on targeted tumor modulation. Ensuring compliance and operational excellence in a hybrid work environment.

Posted 6/22/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesLead💰 $315,000 - $371,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.
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.
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.
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.
Ability to build, inspire, and lead a high-performing QA organization.
Skill in developing scalable teams, mentoring talent, and fostering cross-functional collaboration.
Own and manage Quality budgets across relevant functions and in alignment CDPs.
Partner with Finance to support LRP scenario modeling.

Requirements

What you’ll need

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

Benefits

Comp & perks

Comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire.
Full-time employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual and company performance.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCPGMPquality systemsregulatory inspectionsKPI mechanismstechnology transfersbatch releasestabilityPPQrisk-based Quality framework

Soft Skills

leadershipcollaborationcommunicationmentoringaccountabilitydecisive judgmentinfluencecross-functional collaborationattention to detailtalent development

Certifications

Bachelor's degree in life sciencesBachelor's degree in chemistryBachelor's degree in engineeringMBAMS