Associate Director - Program Management – Quality & Compliance Programs

About the Position

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 utilizing and/or creating 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.