Lead external partner business and technical governance, including selection and strategic development of CMOs, CDMOs, suppliers, and other critical partners; establish performance expectations and governance mechanisms, oversee business reviews, scopes of work, proposals, change orders, contract and supply agreement support, and escalation of commercial or operational issues; and develop business continuity, capacity, and second-source strategies for critical manufacturing capabilities and materials. Provide senior technical review and oversight of manufacturing and process documentation, process performance, significant vendor changes, investigations, annual/product reviews, and significant deviations, out-of-specification or atypical results, and complex manufacturing problems; ensure robust technical investigation, root-cause analysis, effective corrective and preventive actions, continued process control, and reliable manufacturing in partnership with Quality Assurance.