Georgia Sloboda

Senior Director, CMC at Latham Biopharm Group

Speaker

Georgia has over 30+ years of experience in the biotechnology/pharmaceutical industry with emphasis in the vaccines and oncology space. Georgia’s background includes experience in Quality Operations, Quality Systems and Compliance, Board of Health Inspection management, Manufacturing Operations/Tech Transfer, CMO oversight and Regulatory Compliance. As the Senior Director of Global Quality Systems for Celgene, Georgia was responsible for implementing best in class solutions across the GxP’s for Document Management, Risk Management, Deviations Management, Complaint management and Laboratory Management. During her tenor, she was responsible to develop the global roadmap and portfolio of best in class systems for the organization. With the acquisition of Celgene in 2019, Georgia led the Quality organization as the GMP lead for the Integration program with Bristol Myers-Squibb.

Prior to that role, Georgia served as the Site Head of Audits and Compliance for Pfizer. In that role, Georgia led the compliance organization for the site to manage best in class processes for Inspection management and audit readiness, Quality Governance Council, Specification limits and review team, global supplier management and organizational management across the network. The team was also successful in leading the PAI efforts for the oncology business for Pfizer, a first in class facility that is licensed to manufacture Mylotarg®. In addition, Georgia served as a Quality lead for the Hospira/Pfizer integration. As the Director of Quality Assurance, Georgia was responsible for Quality oversight for drug substance and formulation of Pfizer’s next generation pneumococcal conjugate vaccine, Prevnar 13®. Georgia’s experience includes key roles in manufacturing operations with product development oversight, analytical method approval, validation, supplier management, contract laboratory oversight, manufacturing, stability, specifications and commercialization. Georgia has in depth experience working with key suppliers, contract laboratories, CMO’s and closed system and sterile filling technologies.

Georgia has a B.S. in Business Administration and an MBA in Finance and Marketing from St. Thomas Aquinas College. Georgia is active with the PDA Metro Chapter and has presented on topics related to Regulatory Compliance and Auditing.