Name variants:
Gwendolen Ye
Contact Information
Last Update
Jul 11, 2022
Email
wy**@fibrogen.com, we**@yahoo.com
Location
San Francisco, CA
Company
Workplace
Colleagues
Work History
Associate Director, Clinical Quality Assurance
409 Illinois St, San Francisco, CA 94158
from Sep 2017
Director, Qa and Gcp Compliance
509 Madison Ave SUITE 306, New York, NY 10022
Jan 2016 — Sep 2016
Associate Director, Clinical Quality Assurance
999 east Arques Ave, Sunnyvale, CA 94085
Contributed for the FDA and EMA approval of Imbruvica for the treatment of CLL, MCL and WM.
Jul 1, 2014 — Jan 2016
Senior Manager, Clinical Qa
Contributed to the FDA approval of Peginesatide (Hematide), an erythropoietic agent, a functional analog of erythropoietin for anemia.
Apr 2008 — Feb 2013
Gcp Auditor
2100 Franklin St SUITE 900, Oakland, CA 94612
Worked on Ceftaroline which was approved by FDA for community-acquired bacterial pneumonia and acute bacterial skin infections.
Nov 2007 — Apr 2008
Gcp Auditor
Worked on MyVax®, for personalized immunotherapy in follicular B-cell non-Hodgkin’s lymphoma.
Mar 2005 — Nov 2007
Education
Occupations
Executive
Deputy Director
IT Professional
Software Tester
Scientist
Biotechnology Professional
Deputy Manager
Chief Executive
Computer Specialist
Biologist
Biological Scientist
Skills
Clinical Trials
Biotechnology
Pharmaceutical Industry
Clinical Development
Life Sciences
Sop
Quality Auditing
Gcp
Quality Assurance
Fda
Drug Development
Clinical Monitoring
Clinical Research
Good Clinical Practice
Quality System
Glp
Good Laboratory Practice
Biopharmaceuticals
21 Cfr Part 11
Cro
Internal Controls
Ctms
Infectious Diseases
Gmp
U.s. Food and Drug Administration
Ind
Edc
Validation
Standard Operating Procedure
Assurance
Oncology
FAQs about Wendy Ye
What's the profession of Wendy Ye?
This professional's job is Associate Director, Clinical Quality Assurance
What are the main profession of Wendy Ye?
These person's professions are Executive and Deputy Director
Where does Wendy Ye currently live?
San Francisco, California is the place where Wendy Ye lives
What is Wendy Ye's email?
The expert's email is wy**@fibrogen.com and we**@yahoo.com.
Where did Wendy Ye work?
This person worked at Aduro Biotech, Fibrogen, Inc..
Where has Wendy Ye studied?
Wendy studied at the University of California, Santa Cruz from 2004 to 2005.
What are the certifications of Wendy Ye?
Wendy Ye received the following certifications: Rqap-Gcp and Society of Quality Assurance.
What languages does Wendy Ye speak?
Wendy Ye speaks English, Mandarin, and Cantonese.