Leotha Francis

About Leotha Francis

Pharmaceutical, Biotech, Manufacturing Professional with more than fifteen years of experience with an excellent track record in Laboratory Testing, Investigation and Management; Manufacturing Supervision and Scheduling; Document and Training Management; and Quality Assurance. Results driven with a reputation for accuracy, foresight, and gaining cooperation of teammates, management and supporting groups to achieve team and company goals.

Experience

1. Associate Director, Global Process Lead, Qms Procedural Documents Governance Controls

   Bristol Myers Squibb

   Jul 2021 — Present

   Serve as the Lead to drive implementation activities for the integrated and optimized QMS Document Management process across GxP sites and functions inclusive of GLP, GCP, GVP, clinical and commercial GMP, and GDP.Lead the design and deployment of the global translation process and global QMS glossary.Manage revision of the Quality Manual, Master QMS Framework, and associated documents and activities.Create necessary work instructions and job aids to supplement the QMS Document Management process during implementation, hypercare and sustainability phases of integration.Assess operating mechanisms and communication strategies to ensure active engagement of members of the QMS Document Community of Practice.Improve and maintain the QMS Document Management SharePoint site in collaboration with the QMS Operational Controls and Lifecycle Management Document Teams.Support integration and optimization of Governance Controls processes as Document Manager to ensure compliance with QMS operating principlesSupport the design, implementation, and deployment of the single integrated electronic document management system for BMS.Identify and track progress against key project milestones partnering with applicable business, quality, and other enabling functions and any external providers to ensure overall project success.Identify and drive continuous process improvement initiatives.Support change control, impact assessment, PQ testing, document updates and training for electronic document management system updates and releases.

Education

• Seton Hall University

  Bachelor's degree