Ornit Bergman serves as the QA Director of Supply Chain at Gamida Cell Ltd., where she leverages over 20 years of extensive experience in the pharmaceuticals and medical devices sectors. Her multifaceted expertise encompasses chemical R&D, quality assurance, regulatory affairs for CMC GMP drug substance...
Ornit Bergman serves as the QA Director of Supply Chain at Gamida Cell Ltd., where she leverages over 20 years of extensive experience in the pharmaceuticals and medical devices sectors. Her multifaceted expertise encompasses chemical R&D, quality assurance, regulatory affairs for CMC GMP drug substance (DS) and drug product (DP), and compliance in production. Ornit's role is pivotal in ensuring that the supply chain adheres to stringent quality standards, thereby safeguarding product integrity from development through to commercialization.
In her current position, Ornit leads a dedicated quality department that focuses on the implementation of robust quality management systems. She is instrumental in overseeing critical projects related to change control and manufacturing process improvement, ensuring that all operations align with Good Manufacturing Practices (GMP) and ISO standards. Her leadership in conducting internal audits and managing external audits of subcontractors and suppliers ensures compliance and fosters a culture of continuous improvement.
Ornit's proficiency in stability studies and product specification development further enhances her ability to drive quality initiatives across cross-functional teams. She is adept at utilizing key performance indicators (KPIs) to monitor quality metrics, facilitating corrective actions when necessary to maintain high standards of product quality. Her strong communication skills and collaborative approach enable her to effectively engage with stakeholders, ensuring that quality remains a priority throughout the supply chain. As a seasoned professional, Ornit Bergman exemplifies a commitment to excellence in quality assurance, making significant contributions to the success of Gamida Cell Ltd. and the broader pharmaceutical industry.
