Kenneth Steinberg

Senior Project Manager in the Development Operations and Portfolio Management group for a leading global biotechnology company, with a focus on transformative initiatives such as an AI-based automated literature review solution.

Provide IT project management advisory and consultancy services to pharmaceutical clients, specializing in CSV, GxP, and Quality.

For a fully-integrated, global pharmaceutical company, Senior IT PM leading cross-functional, global programs

Operational PM, managing changes to production systems, primarily Veeva Vault, focused primarily in the Clinical, Medical Affairs, Quality, and Regulatory domains. Establish “templatized” governance at the project level, and broader, overall governance at the operational level.

insight and control. Signature project involved implementation of a human sample management platform to provide oversight of human sample lineage and compliance with informed consent, and as the initial use case for a broader Research Data Lake initiative.

Led eight, simultaneous platform migrations as part of acquisition of two new sites. Provided compliance and Quality oversight; managed performance to milestones for multiple cross-functional, cross-site teams; assessed adequacy of change plans, data verification / validation plans; and maintained timely and open communication with stakeholders.

Manage GxP systems SDLC, both for changes to existing production systems as well as implementation projects, including associated change management, business process improvement and governance. Plan and manage project budgets, schedules and cross-functional, matrix project teams.

Directed GxP systems planning, project management, development, validation, and production support. Jointly developed IT quality management, security, and project management methodologies. Led change management process for both GxP and non-GxP IT changes. Managed development of all IT-related SOPs.

Managed application development and implementation projects for Eisai network companies, both validated and non-validated systems. Led cross functional, globally matrixed project teams through the full SDLC. Managed all aspects of project, system and validation lifecycles.

Implemented $2M custom Chemistry, Manufacturing and Controls (CMC) intranet application to centralize and standardize CMC data for Pfizer's Global Manufacturing Compliance group.

Secondary school education