quality regulatory specialist sme at conceptual mindworks inc@ Conceptual MindWorks, Inc
Washington, District Of Columbia, United States
Wylie McVay
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Temple University - Lewis Katz School of Medicine
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FlashIntel GPTWylie McVay is an accomplished scientist, regulatory strategist, quality professional, and business leader with 35.9 years of experience. She has expertise in FDA regulations, regulatory affairs, validation, and quality systems. Wylie has worked in various roles, including as a Quality Regulatory Specialist SME at Conceptual MindWorks, Inc. and as an Associate Director Regulatory Cmc at Windtree Therapeutics, Inc. She is also a co-author of "Pharmaceutical Process Design and Management" and has presented over twenty sessions on effective implementation of lifecycle control strategies. Wylie is based in the United States.
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About
Accomplished scientist, regulatory strategist, quality professional and business leader. Recognized expertise in quality and regulatory affairs. Experienced in QA/CMC lifecycle management of tablets, capsules, liquids, ointments, aseptic fill, terminal sterilization, creams, API, and excipients. Working knowledge of labeling and advertising. Experienced in e-CTD submissions and backbone maintenance. Experienced in global dossier post approval changes, i.e. Variations, amendments and supplements. Results include increased productivity, reduced regulatory compliance risk and sustainable competitive advantage through clear, simple regulatory content. Co-author of “Pharmaceutical Process Design and Management” (Gower, 2012). Contributing author to RAPS Focus, Journal of Validation Technology and Journal of GxP Compliance. Presenter of over twenty sessions dealing in effective implementation of lifecycle control strategies. Member Editorial Review Board of AdvanStar Publications. Specialties: Designing for Quality Assurance Designing for Quality Control Process Lifecycle Management Regulatory Change Control, Global
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quality regulatory specialist sme at conceptual mindworks inc
Biotechnology Research
Wylie McVay's Professional Milestones
- Senior Manager Global Cmc (2005-04-01~2010-06-01): Driving successful global operations to optimize revenue and exceed revenue targets globally.
- Associate Director Regulatory Cmc (2011-01-01~2012-12-01): Implementing robust regulatory compliance initiatives for maximum protection and regulatory adherence.
Education
Quality Assurance / Regulatory Affairs
2006-2010Skill
Fda
Regulatory Affairs
Validation
Quality System
Regulatory Submissions
Quality Auditing
Pharmaceutical Industry
Biotechnology
Gmp
Quality Assurance
Gxp
Sop
21 Cfr Part 11
Technology Transfer
Glp
V&v
Clinical Trials
Regulatory Requirements
U.s. Food And Drug Administration
Capa
Analytical Chemistry
Biopharmaceuticals
Gcp
Lifesciences
Standard Operating Procedure
Good Laboratory Practice
Corrective And Preventive Action
Certification
Colleagues
Hector Pena
Engineering Manager
Bertha Ramirez
Team Member Services | Human Resources Manager
Vincent Lopez
administrative assistant at conceptual mindworks inc
George Irving
Vice President
Robert Stahl
project manager at conceptual mindworks inc
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Wylie McVay works for Conceptual MindWorks, Inc
Wylie McVay's role in Conceptual MindWorks, Inc is quality regulatory specialist sme at conceptual mindworks inc
Wylie McVay works in the industry of Biotechnology Research
Wylie McVay's colleagues are Hector Pena,Bertha Ramirez,Vincent Lopez
Wylie McVay's latest job experience is quality regulatory specialist sme at conceptual mindworks inc at Conceptual MindWorks, Inc
Wylie McVay's latest education in Temple University - Lewis Katz School of Medicine
