Carol Winnefeld
Director Quality, Strategy & Operations, Thermo Fisher Scientific at Thermo Fisher Scientific | Bloomington, Indiana, United States
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Carol Winnefeld serves as the Director of Quality, Strategy & Operations at Thermo Fisher Scientific, where she plays a pivotal role in ensuring the integrity and compliance of the Clinical Trial Division (CTD). With extensive experience in the pharmaceutical industry, Carol brings a wealth of expertise in regulatory compliance, particularly in navigating the complexities of U.S. Food and Drug Administration (FDA) regulations. Her leadership in developing and implementing quality strategies is crucial for maintaining operational excellence and ensuring that all clinical trials are conducted in a safe and compliant manner.
In her current role, Carol is responsible for coordinating global policy and standard operating procedure (SOP) development, which is essential for harmonizing quality practices across various regions and functions. She leads the global change control initiatives within the division, ensuring that any modifications to processes or systems are rigorously evaluated and documented to uphold the highest standards of Good Manufacturing Practice (GMP). Additionally, Carol is adept at analyzing quality metrics and trends, enabling her to proactively identify areas for improvement and implement corrective and preventive actions (CAPA) that enhance overall quality operations.
Her background in public health, combined with her skills in aseptic processing and contract manufacturing, positions her as a key player in the biopharmaceutical landscape. Carol's commitment to fostering a culture of quality and compliance not only supports the operational goals of Thermo Fisher Scientific but also contributes to the advancement of safe and effective therapies for patients worldwide. Through her strategic vision and hands-on approach, she continues to drive innovation and excellence within the clinical trial framework, ensuring that the company remains at the forefront of the pharmaceutical industry.
Director Quality, Strategy & Operations, Thermo Fisher Scientific at Thermo Fisher Scientific in June 2022 to Present
Quality Director, Contracts at Thermo Fisher Scientific in March 2018 to June 2022
Quality Lead at Baxter International Inc. in January 2017 to March 2018
Contract Manager at Baxter International Inc. in April 2006 to January 2017
Quality Project Manager at Baxter International Inc. in January 2004 to April 2006
Quality Supervisor at Baxter International Inc. in August 2001 to January 2004
Quality Assurance Supervisor at Cook Pharmaceutical Solutions in January 1998 to January 2001
Quality Associate at Cook Pharmaceutical Solutions in January 1994 to January 1998
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Pharmaceutical Industry
FDA
GMP
Validation
Quality System
Change Control
CAPA
Sop
Aseptic Processing
Quality Assurance
Regulatory Requirements
Quality Management
Contract Manufacturing
Regulatory Affairs
Biopharmaceuticals
SOP
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
Standard Operating Procedure (SOP)
U.S. Title 21 CFR Part 11 Regulation
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Discover more about Thermo Fisher ScientificWhat is Carol Winnefeld email address?
Email Carol Winnefeld at [email protected] and [email protected]. This email is the most updated Carol Winnefeld email found in 2026.
What is Carol Winnefeld phone number?
Carol Winnefeld phone number is +18127979344 and +18123222718.
How to contact Carol Winnefeld?
To contact Carol Winnefeld send an email to [email protected] or [email protected]. If you want to call Carol Winnefeld try calling on +18127979344 and +18123222718.
What is Carol Winnefeld net worth?
Carol Winnefeld has an estimated net worth of $750,000 to $999,999
What company does Carol Winnefeld work for?
Carol Winnefeld works for Thermo Fisher Scientific
What is Carol Winnefeld's role at Thermo Fisher Scientific?
Carol Winnefeld is Director Quality, Strategy & Operations, Thermo Fisher Scientific
What industry does Carol Winnefeld work in?
Carol Winnefeld works in the Biotechnology Research industry.
Carol Winnefeld Email Addresses
Carol Winnefeld Phone Numbers
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