Kaleo Software

Operations

• 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.

Vice President, Technical Operations

Compliance

• Develops and implements regulatory strategies to facilitate the progress of programs in all phases of development.
• Prepare annual reports, supplements, amendments, and change notifications to regulatory agencies and ensure periodic reports are submitted to regulatory dossiers.
• Participate with team members in drafting and submitting dossiers in different regions around the world, including Chemistry, Manufacturing, and Controls (CMC); nonclinical; human factors; clinical; and pharmacovigilance activities.
• Assist in drafting and reviewing product labeling.
• Review clinical and non-clinical study protocols and other documentation, and assess clinical study related changes to determine regulatory impact.
• Review human factors study protocols and other human factors documentation.
• Support regulatory audits, as required.
• Assist in developing and maintaining Regulatory Affairs department procedures.

Vice President, Technical Operations

Senior Specialist, Regulatory Affairs