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.
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 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.
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.