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.
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.
Provide strategic quality oversight for global clinical operations, including decentralized clinical trials and patient-focused healthcare services.
Ensure compliance with global regulations, sponsor expectations, and established quality systems through risk management and continuous improvement.
Lead investigations, audits, and CAPA activities to support safe, efficient, and reliable clinical trial delivery.
The partner company is a mission-driven organization focused on improving access to healthcare solutions. They foster a supportive, inclusive, and collaborative work environment with a remote-first culture.
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.
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.