Plan and conduct GxP audits (internal, vendor, site) to ensure compliance with FDA regulations and GCP.
Develop risk-based audit plans, communicate observations, and track corrective actions until closure.
Escalate critical deficiencies to leadership and support inspection readiness through key staff interviews.
Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. As a subsidiary of McKesson, we bring together more than 1,300 physicians and have contributed to pivotal research that led to the majority of new cancer therapies approved by the FDA in the past decade.
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.