Winnie C.
About Winnie C.
Winnie C. is an Associate Director of R&D Quality and Medical Governance at Kite Pharma, with a strong background in clinical quality assurance and regulatory compliance. She has over a decade of experience in conducting GCP inspections and facilitating product approvals globally.
Work at Kite Pharma
Winnie C. serves as the Associate Director of R&D Quality and Medical Governance at Kite Pharma. She has held this position since 2021, contributing to the company's commitment to maintaining high standards in research and development quality. Her role involves overseeing medical governance and ensuring compliance with regulatory requirements. Winnie is based in Singapore and continues to play a vital role in the organization's efforts to advance innovative therapies.
Previous Experience at Bristol Myers Squibb
Prior to her current role, Winnie C. worked at Bristol Myers Squibb as the Associate Director for Clinical Trial Inspection Lead, R&D Quality, Clinical Trial Systems & Auditing QA. She was employed there from 2020 to 2022, during which she focused on enhancing clinical trial quality and compliance. Her experience in this role contributed to the effectiveness of clinical trial systems and auditing processes.
Career at Celgene
Winnie C. has significant experience from her tenure at Celgene, where she held multiple positions. From 2019 to 2020, she worked as the Associate Director of Clinical QA (CQA). Prior to that, she served as Sr. Manager - GCP Auditor - Clinical QA (CQA) from 2009 to 2019. Throughout her time at Celgene, she was instrumental in conducting GCP inspections and ensuring compliance with regulatory standards.
Education and Expertise
Winnie C. holds a Master of Science (MSc) degree from the University of London. She also studied at the University of Sydney. Her educational background supports her extensive expertise in clinical quality assurance and regulatory compliance, particularly in Good Clinical Practice (GCP) inspections and auditing.
Contributions to GCP Inspections
Winnie C. has played a key role in conducting inspection risk assessments for global health authority inspections. She has extensive experience coordinating GCP inspections across multiple regulatory bodies, including the FDA, MHRA, EMA, Health Canada, NMPA, TFDA, and PMDA. Her contributions have facilitated successful GCP inspections that have led to product approvals on a global scale.