Tracy Guldan
Head of Quality Systems at Civica Rx | Raleigh-Durham-Chapel Hill Area
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Head of Quality Systems at Civica Rx in February 2024 to Present
Consultant and Owner at Bespoke Global Quality in January 2023 to February 2024
VP, Global Quality Assurance at Precision For Medicine in August 2022 to January 2023
Senior Director, Product Quality Compliance at NOVAVAX INC in June 2021 to April 2022
Global Quality System Lead COVID-19 Vaccines at Johnson & Johnson in October 2020 to June 2021
Global Director, eCommerce Quality & Compliance at Johnson & Johnson in November 2018 to October 2020
Director, Distribution Quality & Compliance at Johnson & Johnson in May 2017 to November 2018
Director, Business Quality, China at Johnson & Johnson in September 2015 to April 2017
Director, Consumer Regulatory Compliance at Johnson & Johnson in April 2014 to September 2015
Director, Enterprise Regulatory Compliance Group at Johnson & Johnson in January 2013 to April 2014
Associate Director, Compliance and Auditing at Novartis Vaccines and Diagnostics in March 2012 to December 2012
Quality Manager, Compliance and Auditing at Novartis Vaccines and Diagnostics in November 2011 to February 2012
Quality Assurance Subject Matter Expert at Novartis Vaccines and Diagnostics in August 2010 to October 2011
Quality Control Manager at Novartis Vaccines and Diagnostics in August 2009 to August 2010
Quality Engineer at Sandoz Novartis in March 2007 to August 2009
Manager - Quality Analyical Labs at Amgen in January 2002 to January 2006
Client Service Manager at Industrial Laboratories in January 1995 to January 2000
Quality Manager at Penwest in January 1994 to January 1995
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University of Phoenix, MA
University of Wisconsin Oshkosh, BS
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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
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Discover more about Civica RxWhat is Tracy Guldan email address?
Email Tracy Guldan at [email protected]. This email is the most updated Tracy Guldan's email found in 2026.
How to contact Tracy Guldan?
To contact Tracy Guldan send an email to [email protected].
What company does Tracy Guldan work for?
Tracy Guldan works for Civica Rx
What is Tracy Guldan's role at Civica Rx?
Tracy Guldan is Head of Quality Systems
What is Tracy Guldan's Phone Number?
Tracy Guldan's phone +44 ** **** *144
Tracy Guldan Email Addresses
Tracy Guldan Phone Numbers
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