Senior Project Manager; FDA Background

Position Overview

We are seeking an experienced Senior Project Manager with a strong FDA background and experience leading Artificial Intelligence (AI) initiatives within regulated environments. The ideal candidate will manage complex projects across FDA programs, ensuring compliance with regulatory requirements while driving innovation through AI, automation, data analytics, and digital transformation solutions.

• Lead the planning, execution, and delivery of FDA-regulated projects and programs.
• Manage cross-functional teams, stakeholders, vendors, and technical resources.
• Oversee project schedules, budgets, risks, and performance metrics.
• Ensure compliance with FDA regulations, policies, and quality standards.
• Drive AI and digital transformation initiatives, including Generative AI, machine learning, automation, and advanced analytics solutions.
• Collaborate with business and technical teams to identify opportunities for AI-enabled process improvements and operational efficiencies.
• Develop project plans, governance frameworks, status reports, and executive briefings.
• Support change management, user adoption, and stakeholder engagement activities.
• Maintain audit-ready project documentation and ensure adherence to regulatory and organizational requirements.

• Bachelor's degree in Business, Information Technology, Life Sciences, Engineering, Public Health, or a related field.
• 8+ years of project or program management experience.
• Experience supporting FDA organizations, FDA-regulated industries, or federal health programs.
• Demonstrated experience managing AI, Generative AI, machine learning, automation, or data-driven transformation projects.
• Strong understanding of FDA regulatory processes and compliance requirements.
• Experience leading cross-functional teams in complex, highly regulated environments.
• Excellent communication, leadership, organizational, and stakeholder management skills.

• PMP, PgMP, Agile, Scrum, or equivalent certification.
• Experience supporting FDA Centers or Programs such as CDER, CBER, CDRH, ORA, HFP, OCE, or related organizations.
• Familiarity with AI governance, responsible AI practices, data management, and emerging technologies.
• Experience with cloud platforms, analytics tools, or enterprise digital transformation initiatives.