Todd Meinecke
Senior Director of Quality Systems and Audits @ADMA Biologics, Inc.
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WORK HISTORY
Senior Director of Quality Systems and Audits @ADMA Biologics, Inc.
Boca Raton, FL, US
Lead the department to ensure compliant Quality Management Systems and both internal and external auditing programs are established and maintained in conformity with applicable company and US/worldwide regulatory requirements, standards, guidance and procedures for the development of drugs and biologics. Manage, direct, oversee and continuously improve Quality Management Systems including Deviations, CAPAs, Change Controls, and internal/external auditing. My role includes development of Lean Six Sigma (LSS) and risk management processes to improve product quality and process efficiency and efficacy. I also support project management related to FDA inspectional responses and large projects within operations and quality at the Boca Raton manufacturing site.
EDUCATION
The University of New Mexico
Bachelor's of Science
The University of New Mexico
Molecular Biology
Regis University
Master of Business Administration (MBA)
ABOUT TODD MEINECKE
With over 24 years of experience in the regulated industry, I have a proven track record of building and maintaining robust quality systems, designing and executing effective regulatory strategies, and ensuring alignment with global standards and best practices. I have a strong background in pharmaceuticals, medical devices, biologics, regenerative / cell engineering and aseptic and terminally sterilized products. I hold a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS), a Masters of Business Administration (MBA) in Healthcare Management from Regis University, and dual Bachelor\'s of Science degrees in Biology and Spanish from The University of New Mexico. I have engaged with small start-up companies all the way to large, multi-national corporations in driving and innovating quality and compliance.
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