Paula Babarovic
About Paula Babarovic
Paula Babarovic is the Director and Therapeutic Area Quality Lead at Bristol Myers Squibb in Boudry, Neuchatel, Switzerland, with extensive experience in quality management and compliance within the pharmaceutical industry.
Current Position
Paula Babarovic currently serves as the Director, Therapeutic Area Quality Lead at Bristol Myers Squibb in Boudry, Neuchatel, Switzerland. Her role involves developing, implementing, and maintaining a quality strategy for the Hematology Therapeutic Area. She manages complex quality issues, ensures successful Health Authority engagement, and supports product submissions, driving continuous process improvements and implementing Quality by Design principles.
Professional Background
Paula Babarovic has a robust background in clinical research and quality management across several notable organizations. She was the Manager Senior Quality Compliance GCP at PMI Science and Innovation in Neuchâtel, Switzerland, from 2019 to 2020. Prior to that, she worked as the Associate Director, Country Clinical Quality Manager at MSD Italia in Milan, Italy, from 2016 to 2019. Additionally, she served as a Sr. Clinical Research Associate-Clinical Project Manager at Covance, a Sr. Clinical Research Associate at Merck, and a Clinical Project Assistant at Sanofi-Aventis. Her extensive experience in these roles showcases her strong project management, negotiation, and problem-solving skills.
Educational Background
Paula Babarovic has an extensive educational background in molecular biology and medicine. She achieved her Bachelor of Science (B.Sc.) in Molecular Biology from the University of Zagreb, Faculty of Science, Department of Biology, from 1997 to 2002. She pursued further specialization at the European Institute of Oncology IEO-IFOM Campus in Milan, Italy, where she completed Specialization Courses for a PhD in Molecular Medicine from 2004 to 2006. Additionally, she studied Molecular Medicine courses at the Max Delbruck Center for Molecular Medicine in Berlin, Germany, from 2002 to 2004.
Skills and Expertise
Paula Babarovic possesses a wealth of skills in managing quality systems, including QMS, Training, and Audit NC&CAPA management. She has strong interpersonal, negotiation, and project management skills. Her knowledge of ICH-GCP, MHRA, and FDA regulations enables her to identify compliance risks and provide strategic directions. She is experienced in working cross-functionally within global teams and all organizational levels, and she provides guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
Quality Management at Bristol Myers Squibb
At Bristol Myers Squibb, Paula Babarovic has designed and implemented an end-to-end quality strategy for the Hematology Therapeutic Area. She oversees the development and maintenance of the program quality plan, manages critical quality issues and serious breaches, and ensures successful collaborations with Health Authorities. Her role involves establishing strong partnerships with business stakeholders and offering expertise in licensing activities. Babarovic’s efforts drive continuous quality process improvements and the application of Quality by Design principles.