Tracy Guldan Email & Phone Number
Head of Quality Systems @ Civica Rx
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Tracy Guldan Location
- Chapel Hill, NC, US
Tracy Guldan Work
- Head of Quality Systems @ (February 2024 - Present)
- Consultant and Owner @ Bespoke Global Quality (January 2023 - February 2024)
- VP, Global Quality Assurance @ (August 2022 - January 2023)
- Senior Director, Product Quality Compliance @ (June 2021 - April 2022)
- Global Quality System Lead COVID-19 Vaccines @ (October 2020 - June 2021)
- Global Director, eCommerce Quality and Compliance @ (November 2018 - October 2020)
- Director, Distribution Quality and Compliance @ (May 2017 - November 2018)
- Director, Business Quality, China @ (September 2015 - April 2017)
- Director, Consumer Regulatory Compliance @ (April 2014 - September 2015)
- Director, Enterprise Regulatory Compliance Group @ (January 2013 - April 2014)
- Associate Director, Compliance and Auditing @ (March 2012 - December 2012)
- Quality Manager, Compliance and Auditing @ (November 2011 - February 2012)
- Quality Assurance Subject Matter Expert @ (August 2010 - October 2011)
- Quality Control Manager @ (August 2009 - August 2010)
- Quality Engineer @ Sandoz Novartis (March 2007 - August 2009)
- Manager - Quality Analyical Labs @ (January 2002 - January 2006)
- Client Service Manager @ (January 1995 - January 2000)
- Quality Manager @ Penwest (January 1994 - January 1995)
Tracy Guldan Education
- University of Phoenix
MA (Organizational Management)
- University of Wisconsin–Oshkosh
BS (Microbiology)
Tracy Guldan Skills
- Leadership
- Remediation
- Inspection
- Global Teams
- Generic Drugs
- Culture Change
- GMP
- Quality Assurance
- CAPA
- FDA
- Change Control
- Pharmaceutical Industry
- 21 CFR Part 11
- Auditing
- Validation
- Biotechnology
- Quality System
- V&V
- Cleaning Validation
- Regulatory Affairs
- Quality Control
- Technology Transfer
- Biopharmaceuticals
- GxP
- Computer System Validation
- Management
- Regulatory Submissions
- Aseptic Processing
- Quality Auditing
- Analytical Chemistry
- HPLC
- Internal Audit
- LIMS
- Life Sciences
- Cross-functional Team Leadership
- Microbiology
- Pharmaceutics
- Regulatory Requirements
- Laboratory Information Management System (LIMS)
- Corrective and Preventive Action (CAPA)
- U.S. Food and Drug Administration (FDA)
- Standard Operating Procedure (SOP)
- U.S. Title 21 CFR Part 11 Regulation
- Quality Management
- Good Manufacturing Practice (GMP)
- Decision-Making
- Business Analysis
- Business Strategy
- Data Analysis
- Data Modeling
Tracy Guldan Summary
- Tracy Guldan, based in Chapel Hill, NC, US, is currently a Head of Quality Systems at Civica Rx. Tracy Guldan brings experience from previous roles at Bespoke Global Quality, Precision For Medicine, NOVAVAX INC and Johnson & Johnson. Tracy Guldan holds a MA in Organizational Management @ University of Phoenix. With a robust skill set that includes Leadership, Remediation, Inspection, Global Teams, Generic Drugs and more. Tracy Guldan has 2 emails and 2 mobile phone numbers on RocketReach.
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Others Named Tracy Guldan
Tracy Guldan
Head of Quality Systems
Chapel Hill, NC, US
Top Civica Rx Employees
Ned McCoy
President and CEO of Civica Rx
Columbus, OH, US
Gregory Larsen
Director of Business Operations
Farmington, UT, US
Nathan Bartlett
Vice President, Business Development
Chapel Hill, NC, US
Paul Abernathy
Head of Information Technology, Civica Rx
Petersburg, VA, US
Adam McCulley
Head of Supply Chain and Procurement
Rolesville, NC, US
Eamon Fitzmaurice
Chief Financial Officer
Chapel Hill, NC, US
Carrie Herbstreit
Vice President Program Management
Denver, CO, US
Michael Laffin
Vice President of Member Accounts
Yarmouth, MA, US
Tracy Guldan
Head of Quality Systems
Chapel Hill, NC, US
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