Clinical Program Quality Excellence Lead - FSP Team

For our client, we are seeking a Clinical Program Quality Excellence Lead - FSP Team to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead program quality excellence efforts focused on clinical operations compliance and inspection readiness across cross-functional study teams. The person in this position will help ensure GCP adherence, strengthen documentation practices, and support teams as they prepare for audits and regulatory inspections. This is a highly collaborative role that partners with SMEs, study teams, and other stakeholders to improve readiness, manage risk, and maintain operational quality across clinical trials. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $110,000 – $130,000 annually Responsibilities Facilitate cross-functional teams' GCP inspection readiness activities Manage inspection readiness planning and develop necessary documentation Guide study teams on adherence to operational processes Engage SMEs in inspection readiness and risk assessment Oversee TMF performance ensuring compliance and inspection readiness Coordinate activities for internal audits and regulatory inspections Provide just-in-time guidance and monitor compliance signals Qualifications 6+ years of clinical research experience in pharmaceuticals or biotechnology Solid knowledge of GCP compliance and regulatory inspection readiness Experience with CROs and outsourcing clinical trial activities; sponsor experience preferred Proficient in clinical trials systems, especially Veeva Strong project management and communication skills Bachelor's degree preferred or equivalent experience Benefits Standard Monday to Friday work schedule Office environment Opportunity for cross-functional collaboration and influence Continuous improvement and professional development initiatives Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.