Stephen Lexa
Site Quality Lead at Eli Lilly and Company | Carmel, Indiana, United States
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As the Site Quality Lead at Eli Lilly and Company, Stephen Lexa plays a pivotal role in the establishment of the new Advanced Medicines Plant in Lebanon, IN. With over 17 years of extensive experience in clinical and commercial pharmaceutical manufacturing, Stephen specializes in sterile dosage forms and brings a wealth of knowledge in aseptic manufacturing processes. His current responsibilities encompass quality oversight during the startup phase of this greenfield manufacturing site, where he is instrumental in building a robust quality organization from the ground up.
Stephen's expertise in regulatory audit management, including navigating VAI/OAI/483s and consent decrees, positions him as a key player in ensuring compliance with stringent industry standards such as 21 CFR Part 210, 21 CFR Part 211, and EU Annex 1. His involvement in facility design and equipment qualification activities ensures that the new plant not only meets regulatory requirements but also adheres to best practices in quality assurance and quality management systems. By evolving the quality management system, Stephen is committed to fostering a culture of excellence and continuous improvement within the organization.
In addition to his technical skills in change control and validation (V&V), Stephen is adept at managing support processes, including investigations and change management initiatives. His leadership is focused on building a winning culture that prioritizes quality and safety, ultimately contributing to Eli Lilly's mission of delivering innovative medicines to patients. As the pharmaceutical landscape continues to evolve, Stephen Lexa's strategic vision and hands-on expertise will be crucial in driving the success of the Advanced Medicines Plant and ensuring the highest standards of product quality.
Site Quality Lead at Eli Lilly and Company in June 2024 to Present
Executive Director - Clinical Manufacturing at Eli Lilly and Company in December 2021 to June 2024
Associate Sr. Consultant, Quality at Eli Lilly and Company in April 2017 to December 2021
Manager - QA BioProcess R&D at Eli Lilly and Company in August 2014 to April 2017
Associate Consultant - Development Quality - Infrastructure, Governance and Improvement at Eli Lilly and Company in September 2013 to August 2014
Manager, Production at Boehringer Ingelheim, Ben Venue Laboratories in August 2012 to September 2013
Manager, Quality Assurance at Boehringer Ingelheim, Ben Venue Laboratories in August 2011 to August 2012
Supervisor, Quality Assurance at Boehringer Ingelheim, Ben Venue Laboratories in April 2008 to September 2011
Manufacturing Floor Auditor I/II, Manufacturing Quality Assurance at Boehringer Ingelheim, Ben Venue Laboratories in February 2006 to April 2008
Financial Advisor at Morgan Stanley in March 2005 to February 2006
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cGMP manufacturing
cGMP practices
Batch Records
Batch Release
Batch Processing
21 CFR Part 11
21 CFR Part 210
21 CFR Part 211
EU Annex 1
FDA
European Union
Trackwise
Project Management
Aseptic Processing
CAPA
Change Control
Cleaning Validation
Formulation
GMP
Pharmaceutical Industry
Pharmaceutics
Quality Assurance
Quality System
V
Validation
TrackWise
V&V
Sop
Standard Operating Procedure (SOP)
SOP
U.S. Food and Drug Administration (FDA)
Verification and Validation (V&V)
Corrective and Preventive Action (CAPA)
U.S. Title 21 CFR Part 11 Regulation
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Discover more about Eli Lilly and CompanyWhat is Stephen Lexa email address?
Email Stephen Lexa at [email protected] and [email protected]. This email is the most updated Stephen Lexa email found in 2026.
How to contact Stephen Lexa?
To contact Stephen Lexa send an email to [email protected] or [email protected]. (updated on October 30, 2024)
What company does Stephen Lexa work for?
Stephen Lexa works for Eli Lilly and Company
What is Stephen Lexa's role at Eli Lilly and Company?
Stephen Lexa is Site Quality Lead
What is Stephen Lexa's Phone Number?
Stephen Lexa's phone (317) ***-*250
What industry does Stephen Lexa work in?
Stephen Lexa works in the Pharmaceutical Manufacturing industry.
Stephen Lexa Email Addresses
Stephen Lexa Phone Numbers
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