Boston, Massachusetts, United States · Hybrid
$167k–$197k/yr
Position Overview Bicara Therapeutics is seeking an Audit Program Lead to own the execution and continuous improvement of Bicara's clinical site, vendor qualification, and internal audit programs. This role requires expe…
Skills: GxP auditing, Clinical site auditing, Vendor qualification, Internal auditing, Risk-based audit planning
Boston, Massachusetts, United States · On-site
Per-diem Nuclear Medicine Technologist Looking for general availability near the schedule below: Hours: 7:00am - 3:30pm Schedule: Tuesday - Friday Garage Parking — options available for a daily or monthly fee, paired wit…
Skills: Nuclear medicine procedures, Radiation detection, Imaging techniques, Patient care, Radiological standards
Boston, Massachusetts, United States · On-site
$90k–$100k/yr
Wind Engineer Karen Clark & Company (KCC) seeks a highly qualified Wind Engineer to join the Model Development Team to work on developing advanced catastrophe reference models. In this position, you will work closely wit…
Skills: Wind engineering, Structural engineering, Civil engineering, Catastrophe modeling, Risk modeling
Boston, Massachusetts, United States · On-site
$74k–$81k/yr
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: Computational biology, Biostatistics, Genetics, Bioinformatics, R
Boston, Massachusetts, United States · On-site
About Wonder Everything’s on the menu at Wonder. Except compromise. Wonder is the mealtime platform built to feed every craving in one order. With Wonder, you can mix and match hundreds of dishes from 20+ exclusive resta…
Skills: Laboratory maintenance, Workspace organization, Facility logistics, Inventory management, Equipment maintenance
Wilson Sonsini Goodrich & RosatiPalo Alto, California, United States · Hybrid
$73k–$110k/yr
Wilson Sonsini is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. We represent companies at every stage of development, from entrepreneurial start-ups to multibillion-dolla…
Skills: Business development, Marketing, Client relationship management, Project management, Market intelligence
Stifel Financial Corp.Boston, Massachusetts, United States · On-site
$110k–$175k/yr
Why Stifel Stifel strives for a culture that puts its clients and associates first: a culture where everyone belongs, everyone is welcome, and everyone contributes to the success of our clients, their careers, and the fi…
Skills: Biotechnology, Equity research, Financial modeling, Fundamental research, Clinical data analysis
Boston, Massachusetts, United States · On-site
$44/hr–$56/hr
Offering a $15,000 sign-on bonus for new external hires Schedule: 7:30am - 5:00pm, 4x9's with set day off No call, weekends, evenings or holidays required. Why you’ll love working at Tufts Medical Center: • Garage parkin…
Skills: Ultrasound technology, MFM ultrasound, Diagnostic medical sonography, Imaging protocols, Patient care
Boston, Massachusetts, United States · Hybrid
Make your mark for patients We are looking for a Data Architect, who is agile and innovative to lead the Patient Solutions Data Foundations team, based in Slough, UK (Windlesham, Surrey 2027), Braine l’Alleud, Belgium or…
Skills: Data Architecture, Metadata Governance, Data Modelling, Enterprise Ontologies, AI-driven Approaches
Warsaw, Indiana, United States · Hybrid
$109k–$175k/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: Python, Machine learning, Artificial intelligence, Tensorflow, Pytorch
Boston, Massachusetts, United States · On-site
$52/hr–$75/hr
POSITION SUMMARY: Responsible for supervising the filling and dispensing of medication orders including the proper handling, usage and storage of drugs. Provides clinical services and drug information to physicians, resi…
Skills: Pharmacotherapy, Pharmacokinetics, Medication management, Clinical pharmacy, Patient rounds
Boston, Massachusetts, United States · On-site
$135k–$382k/yr
Assistant or Associate Professor, Cornea, External Disease, & Refractive Surgery Specialist New England Eye Center at Tufts Medical Center Boston, Massachusetts The New England Eye Center (NEEC) in Boston, MA is seeking …
Skills: Ophthalmology, Cornea surgery, External disease management, Refractive surgery, Clinical research
Boston, Massachusetts, United States · On-site
$90k–$100k/yr
Karen Clark & Company (KCC) is seeking talented structural engineering professionals to join our growing team of catastrophe model developers. In this role, you will collaborate closely with scientists and engineers to e…
Skills: Structural engineering, Catastrophe modeling, Building vulnerability modeling, Forensic engineering, Post-event damage surveys
Boston, Massachusetts, United States · On-site
$52/hr–$75/hr
POSITION SUMMARY: Responsible for supervising the filling and dispensing of medication orders including the proper handling, usage and storage of medications. Provides clinical services and drug information to physicians…
Skills: Clinical pharmacy, Medication dispensing, Drug information, Pharmacotherapy, Sterile products
Boston, Massachusetts, United States · Hybrid
$173k–$273k/yr
Job Description The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of t…
Skills: Atherosclerosis, Clinical research, Clinical development, Drug development, Clinical trials
Boston, Massachusetts, United States · On-site
$35/hr–$38/hr
Job Description The cell and gene analytical technologies team within Vertex cell and genetic therapies (VCGT) is seeking an individual for 6-month contract who can serve as a key contributor in expanding our testing cap…
Skills: Cell culture, Molecular biology, RT-qPCR, ELISA, Flow cytometry
San Francisco, California, United States · On-site
$148k–$220k/yr
At Amazon Web Services (AWS), we are seeking a Life Sciences Business Development professional to join our Healthcare and Life Sciences Applied AI Solutions (AAIS) Go to Market (GTM) organization. In this role, you will …
Skills: Business development, Cloud computing, Life sciences, Go-to-market strategy, Artificial intelligence
Boston, Massachusetts, United States · On-site
$60/hr–$70/hr
Job Description Department: Material Operations – Site PlanningLocation: Boston, MAClassification: GMP Manufacturing / Science Job Summary The Supply Chain Analytics Lead supports Vertex Cell and Genetic Therapies (VCGT)…
Skills: Supply chain analytics, Data modeling, Power BI, Excel, KPI development
Boston, Massachusetts, United States · On-site
$41/hr–$60/hr
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. Proposed Shift: MON-TH 1p-11p $20,000 Sign On Bonus (Some restrictions apply) Job Description: Job Summary:…
Skills: Radiology exams, Patient positioning, Image evaluation, Medical radiography, Basic life support
Boston, Massachusetts, United States · On-site
$127k–$174k/yr
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 assessment, Medical history taking, Diagnostic testing, Treatment planning, Bedside procedures
Boston, Massachusetts, United States • Hybrid
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The Senior Manager, GxP Audit Program Lead is responsible for the end-to-end execution of clinical site, vendor, and internal audit programs. This includes managing audit schedules, facilitating risk-based site selection, overseeing CAPA resolution, and ensuring organizational compliance with global regulatory standards.
Candidates must possess a Bachelor's degree in life sciences and over 8 years of experience in biotech or pharmaceutical quality assurance. A deep understanding of GxP requirements, regulatory agency inspections, and strong leadership skills in audit coordination are essential.
Bicara Therapeutics is seeking an Audit Program Lead to own the execution and continuous improvement of Bicara's clinical site, vendor qualification, and internal audit programs. This role requires expertise in the nuances of clinical site and vendor audits, along with the judgment to evaluate compliance risk, the communication skills to influence outcomes across internal and external stakeholders, and the independence to drive timely program execution. The ideal candidate operates as a trusted subject matter expert and program owner, anticipating program needs and keeping multiple concurrent audit workstreams on track with precision.
This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.
Responsible for ensuring the execution of the risk-based audit program, including the master audit schedule, annual audit schedules, qualification methodology, and requalification cadence across clinical site, supplier/vendor, and internal audit domains.
Lead end-to-end execution of clinical site and vendor audits, facilitate risk-based site selection, audit planning, agenda development, on-site/remote execution oversight, report finalization, and response resolution, and CAPA completion.
Apply understanding of GxP requirements and compliance risk factors to tailor audit scope and depth appropriately, and perform initial review of audit reports, observations, and responses.
Maintain a current, accurate qualified vendor list.
Track Quality Agreement status and revisions.
Lead end-to-end execution of internal audits assessing the state of process compliance; facilitate execution logistics, track findings through resolution, guide SMEs through root cause analysis and CAPA development.
Interpret and apply global regulations and guidance documents, assessing organizational compliance.
Support inspection readiness activities and regulatory agency inspections, by acting as a member of the Quality Inspection team, supporting hosting logistics, aide in readiness preparations and representing the audit program as a credible, well-prepared SME.
Manage contract auditors conducting audits, ensuring quality, consistency, and regulatory rigor in findings and reporting.
Manage relationships with contract auditors and external auditees, exercising strong influence and negotiation skills to resolve scheduling conflicts, and ensure scope & observation alignment.
Process CDAs, contracts, POs, and invoices for contract auditors; verify auditor qualifications prior to engagement.
Facilitate observation tracking and trending to identify potential compliance risks and systemic gaps across audit findings, communicate findings to Quality leadership.
Collaborate with QA counterparts to identify emerging risk areas and adjust audit priorities and scope accordingly.
Own audit program metrics and reporting to Quality Leadership, communicating status clearly and proactively.
Continuously refine audit processes, tools, and templates to improve program efficiency and audit quality.
Ensure audit records are maintained within Bicara's QMS (Veeva, Egnyte GxP) with high accuracy and are audit-ready at all times.
Review compliance documents, SOPs, and protocols as assigned.
BS degree in life sciences or related field.
8+ years of experience in biotech/pharmaceutical including 5+ years in Quality Assurance, with significant hands-on audit coordination and execution experience, specifically in clinical site auditing.
Demonstrated ability to work autonomously, manage competing priorities, and drive audit program execution with minimal oversight.
Auditor certification (e.g., ASQ CQA, RAB, or equivalent) preferred.
Deep, practical understanding of the nuances and complexities of GxP audits, including working expertise in vendor/site- risk assessment, risk based qualification approaches, and audit responses.
Working knowledge of vendor qualification and internal auditing processes
Extensive knowledge of global GMP/GCP regulatory requirements (FDA, EU, ICH) and industry best practices.
Excellent written and verbal communication skills, with proven ability to influence stakeholders at multiple levels, internally and externally.
Exceptional organizational skills and high attention to detail and accuracy, with the ability to manage multiple concurrent audits without dropped details.
Strong critical thinking and pragmatic problem-solving skills; able to identify issues and independently propose solutions.
Up to 10% travel (domestic and international).
Additional accreditations/certifications in quality or auditing.
Experience training, mentoring, or managing auditors.
Direct experience hosting or supporting regulatory agency inspections.
Experience leading process improvement initiatives across a quality organization.
Proficiency with Veeva or similar compliance/QMS software.
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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