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Bouwien Smits

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Bouwien Smits

Site VP and General Manager | Civica Rx

Washington, District of Columbia, United States

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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.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Leadership Development

Emerging Technologies

Organisational experience

Corporate Experience

Bouwien Smits

Work Experience

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Site VP and General Manager at

Civica Rx

October 2023 - Present

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Vice President Of Quality at

Sage Therapeutics

January 2020 - October 2023

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Site Quality Head at

Takeda Pharmaceuticals America, Inc.

August 2017 - January 2020

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Senior Vice President, Quality at

CSBio

January 2015 - January 2017

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Director IT, Manufacturing Information Systems, Validation and Laboratory Operations at

Gilead Sciences Austria

January 2014 - January 2015

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Director, Quality at

Gilead Sciences Austria

January 2011 - January 2014

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Associate Director, QA at

Gilead Sciences Austria

January 2009 - January 2011

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Associate Director, QA at

CV Therapeutics

January 2006 - January 2009

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Senior Manager, QA at

January 2003 - January 2006

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Manager, QA at

CV Therapeutics

January 2000 - January 2003

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QA Specialist III at

Systemix A Novartis

January 2000 - January 2000

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Research Associate II at

Dendreon

January 1997 - January 2000

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Research Associate I at

Dendreon

January 1997 - January 1997

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Bouwien Smits

Education

Santa Clara University, Master Of Business Administration (M.B.A.)

January 1998 - January 2003

Stanford University

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

mail

*************@civicarx.org

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Donna Gulbinski

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Debbi Ford

Ongoing Support for Civica's Work to Make Essential Meds Available and Affordable!

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Eamon Fitzmaurice

Chief Financial Officer

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Carrie Herbstreit

Vice President Program Management

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Todd Allen

Executive Director, Member Accounts

Jay Benson

Chief Manufacturing and Supply Chain Officer

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