Carolyn Mcfarlane
About Carolyn Mcfarlane
Carolyn Mcfarlane is the Associate Director, Audits and Inspections Global Process Owner at Bristol-Myers Squibb and a Program Manager in Clinical Quality Assurance at Takeda Pharmaceuticals, with extensive experience in clinical trial quality and management.
Title: Associate Director, Audits and Inspections Global Process Owner
Carolyn Mcfarlane holds the title of Associate Director, Audits and Inspections Global Process Owner at Bristol-myers Squibb. In this role, she is responsible for overseeing global protocols related to audits and inspections. Her work is crucial in ensuring regulatory compliance and maintaining high standards in clinical trials.
Company: Bristol-myers Squibb and Takeda Pharmaceuticals
Carolyn currently works in dual roles at two major pharmaceutical companies. At Bristol-myers Squibb in New Jersey, she serves as Associate Director, Audits and Inspections Global Process Owner. Concurrently, she is the Program Manager for Clinical Quality Assurance at Takeda Pharmaceuticals in Tokyo, Japan. Her responsibilities at Takeda include providing Good Clinical Practice (GCP) consultations and leadership to clinical teams focused on gastroenterology and neuroscience, as well as to CRO partners and contract auditors.
Education and Expertise: Psychology at Brooklyn College
Carolyn earned her Bachelor of Arts in Psychology from the City University of New York - Brooklyn College. With twelve years of clinical trial quality management experience and seven years in leadership roles, she is highly knowledgeable in ICH GCP, FDA regulations, and NCI guidelines.
Background: Memorial Sloan Kettering Cancer Center Experience
From 2007 to 2018, Carolyn worked at Memorial Sloan Kettering Cancer Center in New York. Starting as a Research Study Assistant I, she progressed to Research Study Assistant II, and eventually Quality Assurance Specialist. During her tenure, she developed a successful QA program in the Department of Pediatrics, including oversight of audits, inspections, monitoring visits, and compliance training.
Achievements: Development of QA Program
While at Memorial Sloan Kettering Cancer Center, Carolyn developed a comprehensive QA program for the Department of Pediatrics. This program encompassed oversight of audits, inspections, monitoring visits, and compliance training, demonstrating her expertise in creating and maintaining quality assurance standards in clinical settings.