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 · On-site
$35/hr–$43/hr
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Scientist – HPLC / KF / GC Shift: Full-Time; Monday – Friday; 8am-5pm EST ONS…
Skills: HPLC, Dissolution Testing, cGMP, Biorelevant Dissolution, Statistical Analysis
Boston, Massachusetts, United States · On-site
$194k–$306k/yr
Job Description At our Company, we are inspired by the belief that a research-driven enterprise dedicated to scientific excellence can create medicines that save and improve lives. Every employee is building on our proud…
Skills: ADME, Assay Development, Bioanalysis, Bispecific Antibodies, Drug Discovery Development
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
$96k–$155k/yr
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Communication, Customer Centricity, Innovation, Market Expansion, Market Research
Boston, Massachusetts, United States · On-site
This is what you will do: The Associate Director, Biostatistics has sufficient experience working as a statistician in the pharmaceutical industry to independently perform and lead statistical work within a project, an i…
Skills: Biostatistics, R, SAS, Clinical Trial Design, Regulatory Strategy
Boston, Massachusetts, United States · Hybrid
$223k–$335k/yr
Job Description General Summary: The Pain Medical Affairs Senior Director or Medical Affairs Director is a critical role in Global Medical Affairs, working on global activities for the Pain disease area. Key responsibili…
Skills: Medical Plan Development, Launch Strategy, Scientific Leadership, External Medical Expert Engagement, Scientific Communication
Boston, Massachusetts, United States · Hybrid
🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls …
Skills: Quantitative Analysis, Qualitative Analysis, Market Research, Problem Solving, Interpersonal Skills
Boston, Massachusetts, United States · On-site
$21/hr–$29/hr
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As …
Skills: Patient Recruitment, Clinical Trial Coordination, Data Collection, Regulatory Compliance, Patient Consenting
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…
Skills: Project Management, Program Planning, Pharmaceutical Product Development, Lifecycle Management, MS Project
Boston, Massachusetts, United States · On-site
Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our missio…
Skills: Patient Preparation, Radiology Equipment Setup, Patient Positioning, Image Processing, PACS
Boston, Massachusetts, United States · Hybrid
Our Mission Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high-quality solutions for our cli…
Skills: Clinical Project Management, ICH-GCP Guidelines, Financial Forecasting, RFP Strategy, Vendor Management
Boston, Massachusetts, United States · On-site
$89k–$121k/yr
Pharmaceutical Sales Representative – Entry Level or Experienced If you are looking to work or break into a Pharmaceutical Sales Representative and promote innovative as well as clinically proven pharmaceutical products …
Skills: Pharmaceutical Sales, Relationship Building, Medical Communication, Negotiation, Persuasion
Boston, Massachusetts, United States · On-site
Site: Brigham and Women's Faulkner Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our m…
Skills: Drug Therapy Optimization, Patient Care, Collaborative Drug Therapy Management, IV Admixtures, Drug Information
Boston, Massachusetts, United States · On-site
Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our missio…
Skills: Drug Therapy Optimization, Pharmacy Services Coordination, Formulary Management, Medication Management, Clinical Interventions
Boston, Massachusetts, United States · On-site
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As …
Skills: IV Admixtures, Drug Information, Ambulatory Pharmacy, Drug Distribution, Medication Safety
Boston, Massachusetts, United States · Hybrid
$220k–$333k/yr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Robotic Process Automation, Intelligent Document Processing, Supervised Machine Learning, Product Strategy, Data Science Platforms
Boston, Massachusetts, United States · Remote OK
$110k–$145k/yr
LIMS Consultant (Post-Sales Implementation) Remote within USA Overview As a LIMS Consultant on our Professional Services team, you’ll play a key role in supporting customers post-sale, with a focus on implementing our ne…
Skills: LIMS Configuration, Requirements Gathering, Validation Testing, Project Management, Python
City of Westminster, England, United Kingdom · Hybrid
Job Description General Summary: The supportive role will contribute to the management and execution of artwork and labelling processes within a regulated pharmaceutical environment. This position focuses on operational …
Skills: Microsoft Office, Data Analysis, Artwork Management, Labeling Compliance, Documentation Accuracy
City of Westminster, England, United Kingdom · Hybrid
Job Description General Summary: The supportive role will contribute to the management and execution of artwork and labelling processes within a regulated pharmaceutical environment. This position focuses on operational …
Skills: Microsoft Office, Data Analysis, Artwork Management, Labeling Compliance, Documentation Accuracy
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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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