Tom Hashimoto

Senior Manager, Quality Document Control

Tom Hashimoto is a high-level expert, who works in Audentes Therapeutics main office of which is in 1096. on the position of Senior Manager, Quality Document Control from 2019. Tom Hashimoto gained professional experience in more than ten positions at different companies. Tom Hashimoto went to the University of California, Berkeley and received education from 1978 to 1981. San Francisco, California is the city, where the professional was known to be settled. Tom's e-mail and phone can be easily accessed through SoftwareOfficial on demand.
Name variants:
Thomas Hashimoto
Last updated Jun 22, 2024

Contact Information

Last Update
Feb 1, 2016
Email
to**@chiron.com, to**@medivation.com, th**@gmail.com
Location
San Francisco, CA

Workplace

Audentes Therapeutics
Senior Manager, Quality Document Control

Industry

Biotechnology

Work History

Senior Manager, Quality Document Control

600 California St, San Francisco, CA 94108
Responsible for the implementation and management of Audentes' quality documentation system and ensuring that documentation and systems are in a state of compliance with current regulations....
from May 2019

Senior Manager, Document Control

New York, NY
Manage global staff of seven Procedure Administrators within the Pharmaceutical Sciences Quality Systems and Compliance group, providing document control support. Responsible for oversight...
Oct 2016 — May 2019

Senior Manager, Document Control

235 east 42Nd St, New York, NY 10036
Manage staff of four to provide document control support. Responsible for ensuring proper and timely execution of controlled document processes. Conduct assessments of complex electronic wo...
Nov 2015 — Sep 2016

Senior Manager, Quality Systems

901 Gateway Blvd, South San Francisco, CA 94080
Responsible for Quality Systems in support of GxP activities: Manage document control function for internal and external documents. Manage training program for GXP employees. Review and ...
Jun 2014 — Nov 2015

Senior Manager, Document Control

901 Gateway Blvd, South San Francisco, CA 94080
Responsible for the Document Control function to ensure compliance with cGMP regulations. Will assess and recommend quality system improvements including full utilization of existing technol...
Feb 1, 2010 — Jun 2014

Sr. Manager, Document Control

Responsible for the Document Control function to ensure compliance with cGMP regulations. Will assess and recommend quality system improvements including full utilization of existing technol...
from Feb 2010

Associate Director, Quality Systems

Manage business analysts in support of Quality IT systems used worldwide. Systems include Document Management (LiveLink), Deviation Management (TrackWise), and Learning Management (WebTraini...
2007 — Mar 2010

Associate Director, Quality Systems

Manage business analysts in support of Quality IT systems used worldwide. Systems include Document Management (LiveLink), Deviation Management (TrackWise), and Learning Management (WebTraini...
2007 — Mar 2010

Associate Director, Document Control

Emeryville, CA
2001 — 2006

Manager, Technical Services

Emeryville, CA
Managed staff of 10-15 in buffer and media preparation, and glassware support for R&D and Manufacturing. Developed buffer formulations and authored SOPs and Batch Records for GMP areas.
1986 — 2001

Education

Occupations

Executive
Manager
Scientist
Biotechnology Professional
Deputy Director
Analysts
Operations Manager
Biologist
Biological Scientist
Deputy Manager
Chief Executive

Skills

21 CFR Part 11
GMP
Change Control
GxP
Gmp
Gxp
21 Cfr Part 11
Quality Assurance
Pharmaceutical Industry
Fda
Validation
Biotechnology
Document Management
Process Improvement
Capa
Sop
Business Analysis
Biopharmaceuticals
Trackwise
Manufacturing
Quality System
Corrective and Preventive Action
Cleaning Validation
Management
Software Documentation
Standard Operating Procedure
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