Manage and oversee the GCP Quality Management System for global clinical operations, including decentralized trials.
Lead quality investigations, CAPAs, and audits to ensure compliance with regulatory standards.
Provide strategic quality advice and drive continuous improvement across the organization.
WEP Clinical partners with biopharmaceutical sponsors to bring treatments to patients through clinical trial delivery and home health services. With over 15 years of global experience, the company fosters a collaborative, innovative culture focused on improving patient outcomes.
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.
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.
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.