Associate Director - Program Management - Quality & Compliance Programs (Hybrid)

Cabaletta Bio Inc
  • Philadelphia, PA
    30+ days ago

    Job Description

    Reporting into the PMO, the Associate Director - Program Management, Quality & Compliance will support the strategic planning, coordination, and execution of all Quality activities across all stages of product development and commercialization. This role operates within the Quality & Compliance department with close collaboration with the enterprise PMO team and cross-functional teams beyond Quality & Compliance. Responsibilities: Partner with various Program Leads of Quality programs to effectively manage the projects and programs. Schedule and lead team meetings including developing agendas, publishing meeting minutes and decision logs, and tracking action items to completion. Initiate and maintain cross-functional collaboration and communication, as needed, to drive project progress and team alignment. Prepare and present slide decks, project reporting and updates to senior management and other key stakeholders to inform and drive decision making. Work with Quality & Compliance Leadership Team to provide scenario planning and project reporting for all Quality & Compliance project management activities, aligning them with company goals and regulatory requirements, including the development and maintenance of charters, dashboards, trackers, schedules and other PM documentation. Routinely perform project planning and due diligence including development of scope, timeline, budget, and resource plan to Quality-focused and Enterprise project portfolio. Extensively support ongoing program management initiatives for the enterprise PMO by utilization and/or creation of project management tools and templates across the company contributing to a continuous improvement culture. Work extensively with the lead Asset PM to support our cross-functional Product Development Team Program (PDT) and the CABA-201 clinical program. Work closely with Clinical Teams, Regulatory Affairs, Technical Development and Supply Chain to support the preparation and submission of regulatory filings, including INDs, and BLAs. Work with all appropriate stakeholders to identify potential project risks, maintain risk registers, conduct risk assessments and develop mitigation strategies to address them proactively. Be a strategic partner with Finance and Legal teams to quickly resolve issues, and facilitate on-time, on budget delivery of project milestones. Work across time zones as necessary. Travel 10-15% may be required. Other duties as assigned. SmartSheet Management: Utilize SmartSheet for project planning, tracking, and reporting both within a singular project and across multiple projects/programs creating one unified portfolio summary/report Create, maintain, and publish SmartSheet dashboards and reports for project status updates. Work with the PMO team to ensure that all department timelines and risk trackers integrate within the overall corporate portfolio and integrated roadmaps. As SmartSheet Super User, train and support team members on SmartSheet use, management, and reporting as well as other functionalities, as needed. Qualifications:

    Numbers & Facts

    LocationPhiladelphia, PA

    Skills

    • Budget Managementunmatched
    • Budgetingunmatched
    • Channel Strategiesunmatched
    • Clinical Practices/Protocolsunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Documentationunmatched
    • Due Diligenceunmatched
    • Financeunmatched
    • Leadershipunmatched
    • Legalunmatched
    • Maintain Complianceunmatched
    • Manage Agendaunmatched
    • Meeting Minutesunmatched
    • Multitaskingunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Product Developmentunmatched
    • Product/Service Launchunmatched
    • Project Management Softwareunmatched
    • Project Planningunmatched
    • Project Trackingunmatched
    • Project/Program Managementunmatched
    • Regulatory Requirementsunmatched
    • Regulatory Submissionsunmatched
    • Reporting Dashboardsunmatched
    • Riskunmatched
    • Risk Analysisunmatched
    • Status Reportsunmatched
    • Strategic Planningunmatched
    • Supply Chainunmatched
    • Team Lead/Managerunmatched
    • Team Playerunmatched
    • Time Managementunmatched
    • Willing to Travelunmatched

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