Ms. Sloboda leads the CMC segment offering for LBG. She has more than 30 years of experience in the biotechnology/pharmaceutical industry with an emphasis in the vaccines and oncology space. Her background includes experience in Quality Operations, Manufacturing Operations/Tech Transfer, Quality Systems and Compliance, Board of Health Inspection Management, External Supply, CDMO Oversight, and Regulatory Compliance.
As the Senior Director of Global Quality Systems for Celgene, Ms. Sloboda was responsible for implementing best-in-class solutions across the GxPs for Document Control, Risk Management, Deviations/CAPA, Complaint, and Laboratory Management. During her tenure, she developed the global roadmap and portfolio of best-in-class systems for the organization. With the acquisition of Celgene in 2019, Ms. Sloboda led the Quality Organization as the GMP lead for the Integration Program with Bristol Myers-Squibb.
Prior to that role, she served as the Site Head of Audits and Compliance for Pfizer, where she 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 also successfully led the PAI efforts for the oncology business for Pfizer, a first-in-class facility that is licensed to manufacture Mylotarg®.
In addition, Ms. Sloboda served as a Quality lead for the Hospira/Pfizer integration. As the Director of Quality Assurance, she was responsible for Quality Oversight for Drug Substance and Formulation Operations of Pfizer’s next generation pneumococcal conjugate vaccine, Prevnar 13®. Her extensive experience includes product development oversight, analytical methods validation, supplier management, contract laboratory oversight, manufacturing, stability, specifications, and commercialization. She also has in-depth experience working with key suppliers, contract laboratories, CMOs, and closed system and sterile filling technologies.
Ms. Sloboda is active with the PDA Metro Chapter and has presented on topics related to CDMO Selection, Supply Chain Optimization, and Compliance and Auditing. She earned a B.S. in Business Administration and an MBA in Finance and Marketing from St. Thomas Aquinas College.
