Dr. Karolina Ebert Email & Phone Number

Multi-skilled and results-oriented quality management professional with extensive experience in enhancing quality standards across diverse departments. My expertise spans various areas, particularly serving as the primary quality contact for Cell and Gene Therapy (C>) manufacturing and actively contributing to the successful implementation of the Advanced Therapy Medicinal Product (ATMP) area within the Quality organization. Notably, I played a key role in evaluating the introduction of the new Annex 1, showcasing my regulatory acumen.Key Achievements:Cross-departmental Quality Leadership:Proven success in elevating quality standards across multiple departments through a tailored, multi-faceted approach adapted to different operational circumstances.First Point of Contact for C> and Launch of ATMP Unit:Pioneering role as the first point of contact for cell and gene therapy, leading quality initiatives and ensuring seamless integration in this innovative area. Oversaw all quality aspects from inception to regulatory approval of the Advanced Therapy Medicinal Product (ATMP) unit.Excellent Document Management:Managed comprehensive documentation, including SOPs, plans, and reports, ensuring compliance with quality objectives across multiple departments/projects.Continuous Quality Improvement:-Quality Event Management: Reviewed and approved non-conformances and deviation reports in all departments while maintaining high-quality standards. Instituted effective corrective and preventive actions (CAPAs) to address root causes and prevent recurrence.-Change Management: Managed, evaluated, and monitored change requests, ensuring smooth transitions and minimal disruptions in quality processes.Risk Management Expert:Defined processes, conducted training, and spearheaded continuous improvement initiatives.Assisted with Audits and Inspections:Actively supported and participated in customer audits and regulatory inspections to resolve quality issues in various areas of the business.Regulatory Compliance Oversight:Led efforts to ensure strict compliance with regulatory requirements and standards, particularly in assessing the implementation of Part IV - GMP requirements for Advanced Therapy Medicinal Products and the new Annex 1.Leadership and Mentorship:Management experience by leading the audit team/supplier qualification team and assuming responsibilities as Deputy QA Head.