Senior Manager, Safety and Quality

Play a critical role in ensuring Alto’s supply chain and manufacturing partners meet the highest standards of patient safety, regulatory compliance, and product quality. This leader will oversee safety and quality programs across our manufacturing relations and supply chain network, drive continuous improvement, and act as a liaison between internal teams, external partners, and regulatory bodies. Develop, implement, and manage safety protocols across supply chain and manufacturing operations. Ensure compliance with FDA, DEA, and state pharmacy regulations, as well as internal company standards. Lead audits and inspections, both internal and external, to verify adherence to safety and quality requirements. Own Alto’s quality management systems (QMS) related to supply chain and manufacturing partners. Establish KPIs and reporting mechanisms to track supplier quality, recalls, deviations, and corrective/preventive actions (CAPA). Partner with manufacturing and logistics teams to resolve quality issues and prevent recurrence. Manage product investigations, complaints, and adverse event reporting in coordination with regulatory teams.