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Bouwien Smits
Bouwien Smits
Site VP and General Manager | Civica Rx
Washington, District of Columbia, United States
Bouwien Smits
Summary
Bouwien Smits is a seasoned executive with over 27 years of extensive experience in the biopharmaceutical and commercial physical research sectors. As the Site VP and General Manager at Civica Rx, she excels in driving operational excellence and strategic leadership. Her background includes significant roles at prominent companies like Sage Therapeutics and Takeda, where she has overseen quality assurance and regulatory compliance, managing teams and navigating complex regulatory landscapes. Bouwien has a proven track record of successfully building high-performing teams and implementing robust quality systems. Her educational credentials include an MBA from Santa Clara University and advanced studies at Stanford and Utrecht University. She is fluent in navigating the intricacies of FDA regulations and has led numerous regulatory inspections, showcasing her expertise in risk management and quality assurance. Bouwien's commitment to innovation and operational excellence sets her apart in the industry.
Bouwien Smits
Work Experience
Site VP and General Manager at
Civica Rx
October 2023 - Present
Vice President Of Quality at
Sage Therapeutics
January 2020 - October 2023
Site Quality Head at
Takeda Pharmaceuticals America, Inc.
August 2017 - January 2020
Senior Vice President, Quality at
CSBio
January 2015 - January 2017
Director IT, Manufacturing Information Systems, Validation and Laboratory Operations at
Gilead Sciences Austria
January 2014 - January 2015
Director, Quality at
Gilead Sciences Austria
January 2011 - January 2014
Associate Director, QA at
Gilead Sciences Austria
January 2009 - January 2011
Associate Director, QA at
CV Therapeutics
January 2006 - January 2009
Senior Manager, QA at
January 2003 - January 2006
Manager, QA at
CV Therapeutics
January 2000 - January 2003
QA Specialist III at
Systemix A Novartis
January 2000 - January 2000
Research Associate II at
Dendreon
January 1997 - January 2000
Research Associate I at
Dendreon
January 1997 - January 1997
Bouwien Smits
Education
Santa Clara University, Master Of Business Administration (M.B.A.)
January 1998 - January 2003
January 1996 - January 1996
Utrecht University, Master’s Degree
January 1996
Frequently Asked Questions about Bouwien Smits
What is Bouwien Smits email address?
Bouwien Smits's primary email address is *************@civicarx.org. To view the full verified email and additional contact details, sign up for free with Muraena.
What company does Bouwien Smits work for?
Bouwien Smits is a Site VP and General Manager at Civica Rx, a company specializing in Pharmaceutical & Medicine Manufacturing.
Where Bouwien Smits graduated from?
Bouwien Smits holds a degree in from Santa Clara University.
How can I directly contact Bouwien Smits?
To contact Bouwien Smits directly, you can use the email address *************@civicarx.org. Complete contact information is available upon registration with Muraena.
Who is Bouwien Smits?
Bouwien Smits is a seasoned executive with over 27 years of extensive experience in the biopharmaceutical and commercial physical research sectors. As the Site VP and General Manager at Civica Rx, she excels in driving operational excellence and strategic leadership. Her background includes significant roles at prominent companies like Sage Therapeutics and Takeda, where she has overseen quality assurance and regulatory compliance, managing teams and navigating complex regulatory landscapes. Bouwien has a proven track record of successfully building high-performing teams and implementing robust quality systems. Her educational credentials include an MBA from Santa Clara University and advanced studies at Stanford and Utrecht University. She is fluent in navigating the intricacies of FDA regulations and has led numerous regulatory inspections, showcasing her expertise in risk management and quality assurance. Bouwien's commitment to innovation and operational excellence sets her apart in the industry.
Bouwien`s contact details
*************@civicarx.org
Colleagues
Vice President of Portfolio Management
Senior Vice President Biopharmaceutical Products
Chief Ethics & Compliance Officer and Associate General Counsel
Chief R&D Officer
Chief Quality & Regulatory Affairs Officer
Ongoing Support for Civica's Work to Make Essential Meds Available and Affordable!
Chief Financial Officer
Vice President Program Management
Executive Director, Member Accounts
Chief Manufacturing and Supply Chain Officer