Senior Manager, External Quality-Supply Chain

Role: Senior Manager, Supply Chain Quality Assurance at a clinical-stage biopharma focused on targeted protein degradation therapies, overseeing quality and compliance across global supply chain operations. Responsibilities: provide quality oversight for materials, manufacturing, packaging, storage, distribution, and logistics; qualify and monitor suppliers, CMOs, warehouses, and transportation partners; participate in audits, manage supplier quality agreements, and ensure Good Distribution Practices compliance; review shipping validation and deviations; and drive continuous improvement in quality processes. Requirements: Bachelor's in chemistry, pharma sciences, or related field; 5+ years in pharmaceutical or biopharma supply chain QA with global distribution experience; deep knowledge of FDA regulations (21 CFR Parts 210/211), ICH guidelines, GMP standards; proven track record managing quality events, deviations, CAPAs, and supporting regulatory inspections; excellent project management and communication skills; willingness to travel domestically and internationally. Preferred: experience in clinical-stage biotech scaling quality operations, familiarity with electronic QMS platforms like Veeva Vault, and knowledge of both development and pre-commercial QA standards. High-Value: GMP, GDP, GCP compliance, global distribution, supplier qualification, regulatory inspections, late-stage development, and clinical supply chain management. Work Setup: not specified; travel required.