John Simon has a B.Sc. from the University of Alberta, is a Senior Member of the American Society for Quality, Certified Quality Auditor (CQA) through the American Society for Quality; Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society; and RQAP-GLP certification through the Society of Quality Assurance. He has held a series of management positions in Quality Assurance and Regulatory Affairs and also work as a consultant.
John was the CEO of the Licensed Producer, GrenEx Pharms May 2015 to January 2018, and is the co-founder and principal with QnR Associates. John supports applicants and License Producers in the Cannabis industry. John has extensive experience in Quality Assurance, Regulatory Affairs, Quality Control and Manufacturing in the Pharmaceutical, Biotechnology, Natural Health Product, Medical Device industries and Cannabis industry. John has supported many clients to establish GMP manufacturing within Canada, USA and other global regulatory jurisdictions.
John has had a variety of experience being directly involved in FDA and Health Canada Audits in the areas of Medical Device Manufacturing, Drug Manufacturing and Testing, Drug and Device Establishments and Clinical Trial sites. Over the years he has gained experience with biologics, pharmaceuticals, medical devices, dietary supplements/natural health products and cosmetic ingredients.