Roberta Ferreira
About Roberta Ferreira
Roberta Ferreira is the Director of Americas Global Quality Regulatory Compliance GCP & PV at Bristol-Myers Squibb in Princeton, NJ, with over 24 years of experience in clinical research and a background in nursing, quality management, and international logistics.
Current Role at Bristol-Myers Squibb
Roberta Ferreira currently holds the title of Director Americas Global Quality Regulatory Compliance GCP & PV at Bristol-Myers Squibb. In this role, she is stationed in Princeton, New Jersey, and oversees a group of auditors involved in a dynamic QA auditing program for the Americas region. Her responsibilities span global process and vendor audits, and she leverages her extensive experience in Clinical Research to manage these tasks effectively. Since joining Bristol-Myers Squibb, she has also gained solid inspection management experience, hosting multiple EMA and FDA inspections both at sites and the BMS headquarters.
Past Experience at QuintilesIMS
Prior to her current role, Roberta Ferreira worked at QuintilesIMS as a Regulatory Affairs Manager from 1996 to 2005. During her nine-year tenure, she built a foundation in regulatory affairs, which has been pivotal in her subsequent roles. Her responsibilities included project management, clinical operations management, and leading regulatory affairs and QA auditing teams. Her time at QuintilesIMS allowed her to develop expertise in inspection processes across various regulatory bodies, enhancing her capabilities for future positions.
Educational Background
Roberta Ferreira has an extensive educational background that complements her professional experience. She earned a Bachelor's degree in Nursing from Universidade Bandeirante de São Paulo from 1994 to 1997. She then pursued Post-Graduation in International Logistics at FGV - Fundação Getulio Vargas in 2004. In 2005, she completed another Post-Graduation in Quality Management and Product Innovation at Mackenzie. Additionally, she holds a master's degree in Pharmacology from CINVESTAV in Mexico City, where she conducted and published research on the effects of curcumin on gastric lesions.
Expertise in Clinical Research and Compliance
Roberta Ferreira brings over 24 years of experience to the field of Clinical Research, specifically in Good Clinical Practice (GCP) and Pharmacovigilance (PV) audits. She has conducted GCP and PV audits globally for 16 years and has experience with regulatory bodies such as Chinese FDA, PMDA, ANMAT, INVIMA, ISP, ANVISA, INS MFDA, and TFDA. Roberta has also implemented efficient inspection management processes across geographies, coordinated FDA mock inspection programs, and focused on process optimization in clinical trials and compliance assessments across multiple therapeutic areas.
Professional Achievements and Personal Interests
Roberta Ferreira has reached notable milestones throughout her career and has been featured in success stories about women in STEM across Latin America. She is passionate about science and technology and has defied stereotypes to pursue a meaningful career in STEM. In her personal life, she is a mountaineer and climber, combining her love for the outdoors with her professional pursuits. Additionally, she is committed to making the achievements of women scientists more visible and has contributed significantly to the field through her research and professional endeavors.