Senior Manager, Clinical Quality

Role: Senior Manager, Clinical Quality at a biotech developing therapies for rare diseases, focusing on clinical trial quality oversight. Responsibilities: provide proactive QA for global Phase I-IV studies, review study documents, identify Critical-to-Quality factors, lead investigations into deviations and noncompliance, conduct audits of sites and vendors, evaluate findings, and support inspection readiness. Develop and improve quality systems and processes, support regulatory inspections, and perform trend analysis for continuous improvement. Requirements: extensive experience in GCP quality assurance within clinical development, with a strong understanding of global regulations (ICH GCP, FDA, EMA, MHRA, Health Canada). Proven track record leading audits, investigations, and vendor oversight in a regulated environment. Preferred: experience supporting clinical trials in rare diseases, especially with cell-penetrating peptide technologies, and familiarity with clinical trial lifecycle management. High-value: oversight of Phase I-IV studies, global scope, cross-functional partnership, vendor and site audits, regulatory inspection support. WorkSetup: approximately 10-15% travel.