Kerry Gagnon is a high-skilled expert, who works in Bluebird Bio main office of which is in 518. as a Senior Director, Quality Systems and Compliance since 2020. Kerry gained professional experience in more than nine positions at various companies. Kerry Gagnon went to the University of Massachusetts Lowell and was studying there. Canton, Massachusetts is the area, where this expert was lastly known to be located. Kerry's email address and number can be accessed through SoftwareOfficial by request.
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Kerry Gagnon
Last updated May 30, 2024
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Workplace
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Work History
Senior Director, Quality Systems and Compliance
60 Binney St, Cambridge, MA 02142
from Mar 2020
Associate Director, Qa Analytics
150 Dan Rd, Canton, MA 02021
Responsibilities included: participation in all regulatory inspections, implementation and maintenance of a single Quality System complying with CDRH and CBER requirements, overseeing CAPA P...
Oct 2011 — Sep 2014
Senior Manager, Qa Analytics and Qa Consultant
150 Dan Rd, Canton, MA 02021
Nov 2008 — Oct 2011
Director of Quality Systems
Developed and implemented plan to bring the Company's Quality Systems and Policies into compliance with FDA and ISO requirements.
Nov 2007 — Jul 2008
Quality Systems Consultant
Laid the groundwork for implementation of Quality Systems designed for start-up company specializing in a medical device and cell-based therapies to improve the survival of patients sufferin...
Nov 2004 — Nov 2007
Quality Systems Consultant
Collaborated with RenaMed Quality personnel to facilitate improvements to Quality Systems policies and procedures. Developed and assisted with the creation and implementation of a Design Con...
Aug 2003 — Oct 2006
Senior Manager, Quality Assurance
Chaired and organized Material Review Meetings (MRB), audited and reviewed contract manufacturers and suppliers, reviewed and approved process/material qualifications, coordinated FMEA and F...
2000 — 2003
Occupations
Executive
Senior Director
Scientist
Biotechnology Professional
Senior Manager
Operations Manager
Biologist
Biological Scientist
Skills
Fda
Capa
Biotechnology
Quality System
Medical Devices
Quality Assurance
Gmp
Sop
Validation
Pharmaceutical Industry
Life Sciences
Biopharmaceuticals
U.s. Food and Drug Administration
Technology Transfer
Standard Operating Procedure
21 Cfr Part 11
Analytics
Change Control
Gcp
Lifesciences
Iso
Design Control
Fmea
Corrective and Preventive Action
Good Clinical Practice
Quality Improvement
Quality Management
Gxp
Deviations
Capas
Quality Investigations