Kaleo Software

• Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development in accordance with Kaleo’s Quality System and 21 CFR 820.30/ISO 13485 • Lead and responsible for human factor engineering activities as per the regulatory guidelines • Work with design, development and manufacturing partners to ensure program execution for the development of Kaleo’s drug delivery devices stay on timeline and within approved budget • Execute Risk Management Programs and Analyses in accordance with Kaléo's Quality System. Utilize Risk Analyses tools including DFMEA, UFMEA and PFMEA in accordance with ISO14971:2019 • Provide leadership for the new products in device design, development, industrialization, stability and pilot clinical activities, execution of design controls and development documentation activities • Help build Kaleo’s intellectual property portfolio • Manage project and program budgets and timelines effectively • Author and review regulatory submissions (as needed) • Responsible for reporting progress, risks, and opportunities to senior management on an ongoing basis to ensure good progress on all development portfolio programs

• Serve as a strategic financial partner and the operational backbone of Kaléo’s Finance function • Lead the annual budget, rolling forecast cycles, and long-range planning • Develop integrated profit and loss (P&L), balance sheet, and cash flow models • Prepare financial materials for the CEO, CFO, Board of Directors, and monthly Finance Committee reviews • Provide financial oversight of the company’s revenue streams • Lead a small Finance team and mentor team members • Ensure effective internal controls and compliance with financial reporting requirements

• Perform supply planning to ensure demand/supply balance is maintained at all levels of the supply chains • Manage the monthly Sales and Operations Planning (S&OP) cycle by preparing plans, information and metrics for Demand, Supply, S&OP and Executive S&OP meetings • Maintain dashboards for broad audiences including the S&OP team and Executives • Effectively and concisely communicate the details of the supply chain planning process to the S&OP team and Executives, providing enough information to make decisions, and additional details as requested • Perform Material Requirements Planning (MRP) to ensure safety stocks are maintained and production requirements are met for all consigned materials, semi-finished goods and finished goods • Issue approved monthly forecasts to suppliers as required by commercial supply agreements • Develop, maintain and monitor adherence to direct spend budgets for all products • Work directly with Finance to forecast and manage cost of goods sold (COGS) • Understand key supply and capacity constraints and support capacity planning efforts • Monitor supplier business compliance to established supply agreements • Support business resilience process by identifying, reporting, and mitigating supply chain risks • Coordinate and monitor domestic and international shipments for raw materials, semi-finished goods and finished products, serving as the primary point of contact with carriers, brokers, and freight forwarders • Ensure Kaleo logistics operations are executed in compliance with applicable laws, regulations and standards • Coordinate product serialization in accordance with FDA regulations, serving as the primary point of contact with Kaleo’s L4 provider and other serialization partners • Collaborate with the Commercial team to coordinate 3PL and channel distribution activities and ensure availability of commercial supply • Support change control, investigations, audits and other critical Quality processes • Work with Quality team to monitor, track and communicate supplier performance

• Oversee Hub and Pharmacy Operations • Serve as the day-to-day point of contact for hub and pharmacy operations • Ensure adherence to contract terms and business rules • Maintain vendor contracts, documentation, and reporting tools • Review and audit all vendor invoices • Oversee and track vendor performance against KPIs • Attend and lead routine meetings with vendor personnel • Identify compliant opportunities for process improvements • Ensure accurate/timely delivery and completion of tasks and projects • Communicate and present data/information regarding program performance, goals, and initiatives to internal and external stakeholders • Define project scope, goals, deliverables, and success criteria for patient access initiatives • Oversee implementation of access‑related projects that enhance the patient and provider experience • Ensure Leadership & Cross-Functional Coordination • Lead external teams by providing guidance, alignment, and support to meet shared targets and deliver key outcomes • Coordinate workflows across internal and external stakeholders to ensure operational alignment • Partner with internal teams (ie. Marketing, Distribution, Market Access, etc.) to ensure alignment and seamless execution • Conduct Data Analysis & Insights • Analyze and track program data to identify trends, barriers, and opportunities • Translate insights into recommendations that guide strategic direction and operational improvements • Maintain dashboards, reports, and performance summaries to support decision‑making

• Audit & Inspection Leadership • Lead regulatory inspections, notified body audits, customer audits, and third-party assessments, including preparation, on-site execution, response coordination, and remediation activities through closure. • Serve as the quality representative for external audit engagements, including direct interaction with regulators, customers, notified bodies, and auditors. • Quality Systems Execution & Improvement • Execute and improve assigned quality systems to ensure sustained inspection readiness, regulatory compliance, and effective audit performance. • Design, implement, and optimize quality system processes to sustain inspection readiness and regulatory compliance. • Apply regulatory requirements, industry standards, and customer expectations to develop practical, risk-based quality system solutions. • Identify quality system gaps, risks, and improvement opportunities through audit outcomes, trend analysis, and quality data review. • Design and implement quality system improvements informed by regulatory intelligence, audit feedback, and operational experience. • Quality Integration & Performance Monitoring • Support quality integration for new product introductions, platform deployments, technology transfers, and customer onboarding activities. • Partner with Development, Operations, Supply Chain, Regulatory Affairs, and Commercial teams to implement quality system requirements and improvements, • Establish and report quality metrics, trends, and management inputs to leadership. • Lead and develop quality systems staff though clear expectations, coaching, and performance management. • Provide oversight of electronic GxP quality systems, ensuring compliance and effective coordination with system administrators responsible for day-to-day configuration support. • Leadership & Management • Lead, manage, and hold accountable assigned Quality Systems personnel, including setting performance expectations, providing ongoing feedback, and conducting performance evaluations in alignment with organizational policies. • Identify capability gaps and support hiring, onboarding, and development activities to ensure the team can effectively execute quality system responsibilities. • QMS Oversight • The Director executes and oversees core elements of the QMS, with direct ownership of key activities, coordination of cross-functional inputs, and accountability for overall system performance, including but not limited to: • Quality Risk & Change Management (Change Management, CAPA, Investigations) • Product & Patient Impact Systems (Complaints, Field Alerts, Product Quality Investigations, APQR) • Documentation & Data Integrity (Document & Record Control, GxP Computerized System oversight) • Supplier & External Quality Oversight (Supplier Quality Management, Internal, Supplier, and Customer Audits) • Inspection Readiness & Regulatory Compliance Intelligence (Regulatory and Notified Body Readiness, Inspection Intelligence) • Quality Performance Monitoring (Quality Metrics, Trending, and Reporting)

• Lead Supply Chain Operations, MS&T, Manufacturing departments. • Ensure activities of the three departments are properly prioritized, harmonized, and executed to support key company strategic objectives. • Maintain a strong relationship with the Quality function to ensure effective collaboration and decision making for technical operations activities. • Accountable for the Kaléo Supply Chain Strategy that includes manufacturing capacity, supply chain resiliency, and product supply strategies to meet Development and Commercial requirements. • Optimize the manufacturing and supply chain footprint to optimally meet current demand requirements with scalability for the future. • Delegate effectively to all direct reports with clearly defined responsibilities and desired outcomes, while providing the necessary resources and support. • Manage goal setting, performance evaluations and manpower planning. • Create and manage all budgets in partnership with direct reports. Approve SOW’s, POs, and Invoices as needed. • Will be a member of Executive Committee for Kaléo. • Participate in quarterly EC meeting, live or virtual. • Build and maintain productive relationships with all departments across Kaléo. • Actively monitor and improve cross departmental communication, collaboration and conflict resolution at the VP level to drive execution and achievement of key strategic objectives. • Provide senior leadership role across the external Kaléo supply chain network. • Participate in CMO Joint Steering Committee meetings for key strategic partners. • Participate in SOW, Supply and Service Agreement negotiations as required. • Work with Supply Chain Operations to identify network gaps and roadblocks. • Collaborate with Kaléo AI Advisory team to develop an AI integration roadmap for Operations.