Boston, Massachusetts, United States · Hybrid
$315k–$371k/yr
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 op…
Skills: Quality Strategy, GCP, GMP, Regulatory Compliance, CMO Oversight
Boston, Massachusetts, United States · Remote OK
$115k–$151k/yr
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Maitland, New South Wales, Australia · Hybrid
$104k–$178k/yr
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Boston, Massachusetts, United States · On-site
$80k–$110k/yr
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Boston, Massachusetts, United States · On-site
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Skills: ADME, Assay Development, Bioanalysis, Bispecific Antibodies, Drug Discovery Development
Boston, Massachusetts, United States · Hybrid
$24/hr–$27/hr
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Boston, Massachusetts, United States · Hybrid
$120k–$140k/yr
For more than three decades, premier organizations have trusted IPM to lead the successful execution of their strategic portfolios and critically important initiatives. Headquartered in Chicago with offices in Boston, Pa…
Skills: Project Management, Program Planning, Pharmaceutical Product Development, Lifecycle Management, MS Project
Boston, Massachusetts, United States · On-site
$150k–$190k/yr
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Boston, Massachusetts, United States · Hybrid
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Boston, Massachusetts, United States · Hybrid
$86k–$95k/yr
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Boston, Massachusetts, United States · On-site
$123k–$338k/yr
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Skills: Siemens MES, Manufacturing Execution Systems, Technical Leadership, Project Estimation, System Integration
Boston, Massachusetts, United States · Hybrid
$100k–$110k/yr
For more than three decades, premier organizations have trusted IPM to lead the successful execution of their strategic portfolios and critically important initiatives. Headquartered in Chicago with offices in Boston, Pa…
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Boston, Massachusetts, United States · On-site
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Boston, Massachusetts, United States · On-site
$92k–$105k/yr
STV is seeking a dynamic Plumbing Designer/Plumbing Engineering Specialist to join our team in the Boston, MA office. The Buildings Division provides design services to both public agencies and private corporations. Curr…
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Boston, Massachusetts, United States · Hybrid
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Boston, Massachusetts, United States · Hybrid
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Boston, Massachusetts, United States · On-site
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Boston, Massachusetts, United States · Hybrid
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Boston, Massachusetts, United States · On-site
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London, England, United Kingdom · On-site
$153k–$186k/yr
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Skills: Generative AI, SaaS Integration, Cloud Technologies, React, Python
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The VP of Quality will develop and execute a holistic quality strategy to transition the company from clinical development to commercial manufacturing. This includes overseeing quality systems, managing external partners (CMOs/CROs), and fostering a company-wide culture of accountability and compliance.
Requires a bachelor's degree in life sciences or engineering with 15+ years of progressive industry experience in quality organizations. Candidates must have a proven track record of leading regulatory inspections and building quality functions in pre-commercial and early commercial environments.
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.
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 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 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 managing 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.
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.
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.
Pioneering bifunctional antibodies for targeted tumor modulation
Bicara is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara has built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This approach was deployed in the development of Bicara’s lead program ficerafusp alfa, formerly BCA101, a bifunctional epidermal growth factor receptor (EGFR) directed monoclonal antibody bound to a human transforming growth factor beta (TGF-β) ligand trap. By combining these two clinically validated targets, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment (TME). Ficerafusp alfa directs the TGF-β inhibitor into the immediate TME through the binding of EGFR on tumor cells, which Bicara believes will lead to deep and durable responses and an increase in overall survival, while reducing the potential adverse effects previously associated with systemic TGF-β inhibition. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com
Offices: Boston, Massachusetts, US
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