Kevin Miodonski
Senior Advisor / Consultant at Pharma Strategic Solutions LLC | Camano, Washington, United States
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Kevin Miodonski serves as a Senior Advisor and Consultant at Pharma Strategic Solutions LLC, where he leverages his extensive expertise in quality management and regulatory compliance to drive transformative initiatives within the Pharmaceutical, Biotech, and Medical Device sectors. With a robust background in leading quality remediation efforts, Kevin has successfully guided numerous global companies through complex challenges, ensuring adherence to GxP standards and enhancing operational excellence. His recent projects include spearheading the remediation of the Design Control process for a top-tier medical device manufacturer, where he implemented critical updates to Standard Operating Procedures (SOPs) and facilitated interim solutions to streamline compliance and operational efficiency.
Kevin's proficiency in key areas such as CAPA (Corrective and Preventive Action), Trackwise, Document Control, and Supplier Control has been instrumental in fostering a culture of continuous improvement and accountability within organizations. His strategic approach to Change Management and Cultural Transformation has empowered teams to embrace new methodologies, ultimately enhancing product quality and regulatory readiness.
With an MBA from Duke University’s Fuqua School of Business, Kevin combines his technical acumen with strong leadership skills, making him a sought-after advisor for companies looking to navigate the complexities of regulatory affairs and operational challenges. His commitment to excellence is evident in his ability to align cross-functional teams and drive initiatives that not only meet compliance requirements but also contribute to long-term business success. Kevin’s insights and strategic vision continue to position Pharma Strategic Solutions LLC as a leader in quality consulting within the industry.
Senior Advisor / Consultant at Pharma Strategic Solutions LLC in March 2012 to Present
Owner at Miodo Chocolate in January 2008 to July 2024
COO at Twinlab in September 2011 to March 2012
VP Operations at New Chapter Inc. in August 2009 to September 2011
COO at Harmony Labs in February 2006 to August 2009
VP Manufacturing Operations at Cell Therapeutics in January 2004 to January 2006
General Manager/Director Global Supply Chain at Solvay Pharmaceuticals in January 1999 to January 2004
Director Operation at Sonus Pharmaceuticals in January 1996 to January 1999
Plant Manager at Procyte in January 1994 to January 1996
Production Manager at Burroughs Wellcome in January 1988 to January 1994
Production Manager at Mentholatum in January 1986 to January 1988
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Duke University - The Fuqua School of Business, MBA, August 1991 to August 1993
Buffalo State University, BS, August 1980 to August 1984
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Project Management Office (PMO)
Global Leadership
Facility Expansion
Manufacturing
FDA
Supply Chain
GMP
Pharmaceutical Industry
Validation
SOP
Cross-functional Team Leadership
CAPA
Quality System
Biotechnology
Regulatory Affairs
Technology Transfer
Logistics
Strategy
Process Improvement
Change Control
21 CFR Part 11
Process Simulation
Start-ups
Product Development
Quality Assurance
R&D
Strategic Planning
Pharmaceutics
GxP
Quality Auditing
Contract Manufacturing
Cleaning Validation
Management Consulting
Regulatory Requirements
Operational Excellence
Aseptic Processing
Management
Project Management
Leadership
Operations Management
Supply Chain Management
Procurement
Business Process Improvement
U.S. Title 21 CFR Part 11 Regulation
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Medical Devices
Change Management
Quality Management
Consulting
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What is Kevin Miodonski email address?
Email Kevin Miodonski at [email protected], [email protected], [email protected], [email protected] and [email protected]. This email is the most updated Kevin Miodonski's email found in 2026.
What is Kevin Miodonski phone number?
Kevin Miodonski phone number is 5862025792.
How to contact Kevin Miodonski?
To contact Kevin Miodonski send an email to [email protected], [email protected], [email protected], [email protected] or [email protected]. If you want to call Kevin Miodonski try calling on 5862025792. (updated on August 26, 2024)
What company does Kevin Miodonski work for?
Kevin Miodonski works for Pharma Strategic Solutions LLC
What is Kevin Miodonski's role at Pharma Strategic Solutions LLC?
Kevin Miodonski is Senior Advisor / Consultant
What industry does Kevin Miodonski work in?
Kevin Miodonski works in the Pharmaceuticals industry.
Kevin Miodonski Email Addresses
Kevin Miodonski Phone Numbers
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