Source Job

• Provide scientific leadership for QC GMP activities, including method transfer and lifecycle management for drug substance and drug product.
• Lead investigations of deviations, OOS, and OOT results, and implement CAPAs.
• Collaborate with cross-functional teams and external partners to ensure compliant QC operations.

Cogent Biosciences is a publicly traded biotechnology company developing novel precision therapies for rare diseases and cancer. With a collaborative culture and offices in Waltham, MA and Boulder, CO, they focus on advancing their pipeline through clinical trials.

• Provide sponsor oversight of CMO QC labs and maintain control strategies for investigational cell therapy products.
• Manage validation of analytical methods and stability programs to support clinical trials.
• Investigate laboratory deviations and ensure risks are managed to resolution.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values of innovation and collaboration, they are a growing company committed to transforming treatment for autoimmune disease.

• Provide first-line technical support to PT participants via email, including result submission and report interpretation.
• Assist with planning and maintaining PT round schedules, program setup, and customer order management.
• Maintain awareness of clinical laboratory developments and assist in identifying new proficiency products.

LGC Proficiency Testing provides clinical proficiency testing programs to laboratories worldwide. The company supports over 20,000 customers in the US and operates globally with a culture focused on science for a safer world.

• Perform clinical data entry and processing activities for assigned studies, ensuring accuracy and compliance.
• Support data management documentation, CRF design, database development, and quality control processes.
• Validate clinical data, generate queries, and perform quality control checks throughout the study lifecycle.

The company supports global clinical research programs by ensuring accuracy, quality, and integrity of clinical trial data through data management activities. They offer a collaborative healthcare-focused environment with professional growth opportunities and flexible remote work.

• Lead the implementation, sustainment, and improvement of various ISO standards and CMMI appraisals for Goldbelt and its subsidiary companies.
• Run and maintain recurring and ad-hoc reports, ensuring accuracy and delivering reliable insights that support stakeholder decision-making.
• Perform data analysis and audits to identify discrepancies, drive improvements, and ensure compliance with government contracting standards.

Goldbelt Incorporated is an Alaska Native Corporation (ANC) headquartered in Juneau, Alaska, whose mission is to make a significant and positive difference in the lives of more than 4,200 Alaska Native shareholders. As a fast-growing company managing over 30 subsidiaries, it provides a shared service center model with a focus on gold standard customer service and professional growth.

• Provides quality oversight of QC laboratory activities, ensuring compliance with global GxP regulations across multiple indications.
• Manages GMP testing at CMOs and contract testing laboratories, including raw data review and exceptions management.
• Collaborates with CMC Manufacturing, Quality Assurance, and Regulatory Affairs to align testing timelines with corporate goals.

Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. They are a publicly traded, clinical-stage biopharmaceutical company with a dynamic, fast-paced, entrepreneurial culture.

• Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
• Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
• Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.

• Build, maintain, and continuously improve the company's Quality Management System (QMS) and oversee GxP CSV requirements.
• Own the design and administration of the electronic QMS, including validation, document control, and compliance activities.
• Lead internal audit and inspection-readiness programs, supporting regulatory inspections and promoting a culture of quality.

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs, targeting the underlying drivers of aging to delay disease and preserve quality of life. As a well-funded startup with teams of scientists, veterinarians, engineers, and creatives, it is pioneering the first FDA-approved lifespan extension medicine.

• Deliver high-quality informatics services including deployment, validation, training, and support for Waters solutions in regulated labs.
• Provide validation consulting across the system lifecycle, ensuring compliance with GxP, 21 CFR Part 11, and Annex 11.
• Act as a trusted advisor, supporting customer relationships, pre-sales activities, and identifying growth opportunities.

Waters Corporation is a global leader in analytical instruments, separations technologies, and software, serving life, materials, food, and environmental sciences for over 65 years. With 7,600+ employees across 100+ countries, the company fosters a collaborative and inclusive culture passionate about pioneering science.

• Act as subject matter expert for the Document Control process area, owning lifecycle management of quality processes and records.
• Serve as System Administrator of Veeva’s internal electronic Document Management System (eDMS), responsible for configuration and continuous improvement.
• Provide quality oversight on regulated activities, such as process definition, validation testing, and product releases for in-scope systems.

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.

• Manage moderately complex projects and support long-term operational initiatives.
• Accurately enter, update, and maintain program data including invoices, staffing, and deliverables.
• Perform data analysis and audits to ensure compliance with government contracting standards.

Goldbelt Incorporated is an Alaska Native Corporation (ANC) headquartered in Juneau, Alaska, dedicated to making a significant positive difference for over 4,200 Alaska Native shareholders. The company manages over 30 subsidiaries and operates as a shared service center model, emphasizing teamwork, gold standard customer service, and professional growth.

• Support GCP/GCLP/GVP audits for investigational sites, internal systems, and clinical service providers, including planning, coordination, and reporting.
• Assist with commercial inspections, inspection readiness activities, and GCP compliance tasks such as investigations and change controls.
• Maintain a continuous improvement mindset and represent the Clinical Quality Assurance Team in cross-functional projects.

Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer patients. The company is a clinical-stage organization with a strong focus on innovation and collaboration in a fast-paced environment.

• Lead Quality Systems and Regulatory Affairs to ensure compliance with FDA, ISO 13485, and EU MDR.
• Optimize the electronic Quality Management System (eQMS) and drive sustainable process improvements.
• Serve as primary quality and regulatory representative during audits, inspections, and regulatory submissions.

CEFALY Technology develops medical devices for migraine relief. It is a growing organization that values quality, compliance, and mentorship.

• Communicate with customers on quality issues and coordinate with regional Quality Teams to resolve concerns.
• Review customer quality requirements and integrate them into the Quality Management System.
• Support APQP and PPAP activities and ensure manufacturing techniques meet specifications.

MISUMI Americas provides standard, configurable, and custom manufacturing solutions with a digital manufacturing platform. The company serves innovative companies in the Americas with operations in San Francisco Bay Area and Chicago.

• Design and execute test strategies for healthcare and medical software applications, including automated and manual testing.
• Validate front-end and back-end functionality, APIs, workflows, integrations, and data integrity.
• Write clear defect reports and communicate findings to help teams make good decisions.

Estenda Solutions develops complex healthcare software with a focus on reliable, usable products. The company offers world-class benefits and operates within an ISO 13485 registered Quality Management System.

• Develop and execute comprehensive test plans and test cases to ensure software functionality, performance, and reliability.
• Create, maintain, and enhance automation frameworks using tools such as Selenium, Cucumber, and integrate testing into CI/CD pipelines.
• Collaborate with stakeholders to define acceptance criteria and ensure Section 508 accessibility compliance.

LMI is a new breed of digital solutions provider dedicated to accelerating government impact with innovation and speed. Headquartered in Tysons, Virginia, LMI serves defense, space, healthcare, and energy sectors.

• Support the development and implementation of quality management systems and continuous improvement initiatives.
• Track performance metrics, identify process optimization opportunities, and collaborate with cross-functional teams.
• Participate in root cause analysis, quality inspections, and assist in training staff on quality practices.

Hitachi Energy is a global technology company leading the energy transition with innovative solutions and services. The company fosters a diverse and inclusive workplace with a strong focus on quality and continuous improvement.

• Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production with a focus on quality and compliance.
• Provide oversight of CROs, vendors, and internal teams, recruiting and leading CDM staff to meet clinical trial timelines and budgets.
• Partner cross-functionally on data management issues, identify risks, and propose solutions to ensure inspection-ready, high-quality data.

Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and traded on Nasdaq (DFTX), the company is advancing a new generation of therapeutics with a focus on turning evidence into impact.

• Perform technical reviews and manage quality assurance for Property Condition Assessments on commercial properties.
• Coordinate team efforts, client communication, and project progress to ensure timely delivery.
• Mentor staff, manage multiple projects, and provide recommendations to clients and relationship managers.

NV5 is a global engineering and consulting firm providing technology, certification, and consulting solutions. The company has a diverse workforce and emphasizes quality and client service.

• Execute manual and automated test cases to ensure product quality and reliability.
• Partner with development and product teams to understand system design and manage test coverage.
• Document defects clearly and report test results, supporting HIPAA-compliant testing standards.

PerfectServe is a leading provider of clinical communication and physician scheduling solutions in the health IT space. The company has 400+ employees, 30,000+ customers, and $100 million+ in annual revenue, with a collaborative team culture.