Sr Advisor Cell and Gene Therapy Manufacturing @ (November 2019 - September 2021)
VP Global Quality @ (April 2017 - November 2019)
VP Global Head Cell and Gene Therapies Technical Development and Manufacturing @ (October 2016 - April 2017)
Head Cell and Gene Therapy Quality @ (June 2014 - April 2017)
Global Head QA, Biopharmaceutical Operations @ (February 2012 - June 2014)
Head QA -BPO Third Party @ (August 2009 - February 2012)
Senior Director, Quality @ (January 2008 - January 2009)
Director, Product Quality @ (September 2006 - December 2007)
Senior Director, Quality Assurance @ (August 2002 - November 2006)
Senior Manager, Regulatory Affairs @ (January 2002 - August 2002)
Associate Director, Quality Assurance @ (February 2001 - December 2001)
QA Validation Manager @ (August 1999 - February 2001)
Regulatory Affairs Senior Specialist @ (March 1996 - February 1999)
Validation Manager, Process Validation @ (January 1994 - March 1996)
Senior Research Associate, Bioprocess @ Bristol Meyers Squibb (January 1991 - January 1994)
Karen Walker Education
St. Olaf College 1979-1983
Karen Walker Skills
GMP
Validation
Biotechnology
Regulatory Affairs
Biopharmaceuticals
Quality Assurance
FDA
Quality System
Pharmaceutical Industry
Quality Management
CAPA
Quality Control
Clinical Research
Change Control
V&V
Manufacturing
Technology Transfer
Aseptic Processing
LIMS
Medical Devices
Cell Therapy
Analytical Method Validation
Process Validation
BPF
Corrective and Preventive Action (CAPA)
Verification and Validation (V&V)
U.S. Food and Drug Administration (FDA)
Marketing
Sales
u.s. Food and Drug Administration Fda
Business Development
Verification and Validation V&V
Corrective and Preventive Action Capa
Strategy
Corrective and Preventive Action
Verification and Validation
u.s. Food and Drug Administration
Karen Walker Summary
Karen Walker, based in Kirkland, WA, US, is currently a Chief Technical Officer at Kyverna Therapeutics. Karen Walker brings experience from previous roles at Genentech, Seattle Genetics, Novartis Pharmaceutical Corporation and Novartis. Karen Walker holds a 1979 - 1983 St. Olaf College. With a robust skill set that includes GMP, Validation, Biotechnology, Regulatory Affairs, Biopharmaceuticals and more. Karen Walker has 2 emails and 5 mobile phone numbers on RocketReach.
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