Oversee GCP quality systems and provide QA leadership for global clinical operations including decentralized trials.
Lead investigations, CAPAs, risk assessments, and audits to ensure regulatory compliance.
Review clinical documentation, support vendor qualification, and mentor QA staff.
WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trial services, home health, and market access solutions. With over 15 years of global experience across 150+ countries, the company fosters a collaborative and mission-driven culture.
Provide strategic leadership and oversight for GCP quality assurance activities supporting clinical development programs.
Lead the development, planning, and execution of GCP audits, including clinical sites, CROs, vendors, and internal processes.
Own regulatory inspection readiness and collaborate with cross-functional teams to ensure compliance with GCP standards.
Cogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for unmet medical needs. The company fosters a collaborative culture and is committed to advancing treatments for rare conditions.
Lead the execution and continuous improvement of quality management systems to ensure compliance with FDA, ICH, GCP, and ISO 9001 standards.
Manage electronic Quality Management System (eQMS) including document control, CAPA, risk management, and audit processes.
Provide quality oversight for clinical trial activities and software development lifecycle, collaborating with cross-functional teams.
The partner company is a fast-growing healthcare and life sciences organization focused on improving clinical research. It values collaboration, curiosity, and continuous improvement, and supports teams through scalable systems and risk management.
Lead and deliver risk-based GCP/GCLP audits across internal and external partners.
Own audit planning, execution, reporting, and CAPA oversight as a subject matter expert.
Coach peer auditors and collaborate globally within the Global Quality Audit team.
Ipsen is a global mid-sized biopharmaceutical group specializing in transformative medicines in oncology, rare diseases, and neurosciences. With nearly 100 years of experience and hubs in the US, France, and UK, the company has passionate teams in over 40 countries and brings medicines to patients in 88 countries.
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.
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.
Support the Quality Management System including SOPs, training, and CAPA processes.
Coordinate and conduct internal audits, vendor audits, investigator site audits, and trial master file audits.
Provide QA consultation and support to project teams, and manage quality issues and corrective actions.
Precision for Medicine is a Clinical Research Organisation that combines novel clinical trial designs with advanced biomarker and data analytics solutions. The company has a strong focus on rare diseases and oncology, with a global team and a culture that values employee contributions and collaboration.
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.
Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.
Lead quality initiatives, audits, and compliance programs to align with client and regulatory standards.
Analyze performance data and collaborate with cross-functional teams to implement process improvements.
Develop executive reports and tools to drive quality excellence and support operational accuracy.
The partner company operates in the US security and IT sector, focusing on quality and operational excellence. It maintains a dynamic, collaborative culture that values continuous improvement and client satisfaction.
Implement and maintain best-in-class quality systems in compliance with FDA, ICH, 21 CFR Part 11, and ISO 9001.
Foster a culture of quality excellence and continuous improvement across the organization.
Manage day-to-day activities of a lean, high-performing quality team and optimize workflows.
N-Power Medicine aims to reinvent drug development by transforming clinical trials through better integration with clinical practice. They are building a multi-disciplinary team with diverse expertise in healthcare, engineering, technology, and regulatory, sharing a core value of empowering community through generosity, curiosity, and humility.
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.
Conduct quality control reviews of participant visits and source documentation in the CRIO eSource system to ensure compliance with GCP, ALCOA principles, and client standards.
Identify missing documentation, inconsistencies, protocol deviations, and transcription errors, and document findings in tracking systems.
Collaborate with site personnel to communicate findings, support corrective actions, and contribute to continuous improvement initiatives.
UniTriTeam is a women-owned global workforce solutions organization specializing in clinical research operations, technology, and strategic staffing support. The team is collaborative, accountable, and committed to delivering excellence and integrity.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Manage clinical operations including study management, biospecimen acquisition, and regulatory compliance.
Lead and mentor a team of CRAs and clinical trial logistics personnel.
Develop and implement processes and tools for high-quality trial management.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to delivering better solutions and have an innovative culture focused on collaboration and cutting edge solutions.
Lead and oversee Commercial Quality operations across the Ergomed Group, including managing Quality Cost Grids and supporting bid activities.
Act as a subject matter expert for GxP Commercial Quality, driving quality input into client proposals and presentations.
Mentor and develop quality staff to enhance their competence and confidence in becoming subject matter experts.
PrimeVigilance is a specialized mid-size pharmacovigilance service provider with staff across Europe, North America and Asia. It values employee experience, well-being and a healthy work-life balance to nurture a high-quality client service environment.
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.
Ensure GxP systems are implemented, validated, and maintained in compliance with regulatory and quality standards.
Provide quality oversight for computerized system lifecycle activities, including vendor evaluations and system qualification.
Lead investigations for CSV-related deviations and data integrity issues, driving root cause analysis and risk mitigation.
Definium Therapeutics is a late-stage clinical biopharmaceutical company developing psychedelic-based treatments for psychiatric and neurological disorders. The company is publicly traded on Nasdaq and focuses on scientific rigor to create accessible mental health treatments.
Create and execute clinical operational strategic plans aligned with product strategy and resource allocation.
Build, develop, and train internal staff and external vendors to enhance efficiency and engagement.
Oversee relationships with Contract Research Organizations, vendors, and investigative sites to ensure compliance with FDA and ICH GCP guidelines.
Lycia Therapeutics is a biotechnology company using its proprietary LYTAC platform to develop therapeutics that degrade extracellular and membrane-bound proteins. Founded in 2019, the company has raised $75 million in Series D financing and is headquartered in South San Francisco.