Ms. Sloboda has more than 30 years of experience in the biotechnology/pharmaceutical industry with emphasis in the vaccines and oncology space. Her 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, Ms. Sloboda was responsible for implementing best-in-class solutions across the GxPs for Document Management, Risk Management, Deviations Management, Complaint Management, 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 of Pfizer’s next generation pneumococcal conjugate vaccine, Prevnar 13®. Her extensive experience includes product development oversight, analytical method approval, 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 Compliance and Auditing. She earned a B.S. in Business Administration and an MBA in Finance and Marketing from St. Thomas Aquinas College.