Senior Manager, Clinical Quality

Role: Senior Manager, Clinical Quality leading quality assurance for clinical-stage biotech focused on rare diseases, notably Friedreich’s ataxia. Responsibilities: oversee GCP compliance across Phase I-IV global studies, review clinical documents, identify critical quality factors, lead investigations of deviations and noncompliance, conduct audits (site, vendor, process), evaluate audit findings and risks, manage vendor quality assessments, develop and improve quality systems, support inspections and corrective actions, and generate quality metrics. Requirements: experience with clinical quality assurance in biotech/pharma, proficiency in GCP, FDA, EMA, ICH regulations, and audit management; strong risk management, investigation, and CAPA skills. Preferred: experience in rare disease clinical development or cell-penetrating peptide technologies. HighValue: oversight of global clinical trials, GCP compliance, risk management, audit leadership, vendor oversight, and inspection support. WorkSetup: approximately 10-15% travel.