With over 40 years of experience in the pharmaceutical, biotechnology, and medical device industries, I am an expert in aseptic commissioning, qualification, and validation (CQV) integrated scheduling. I currently work at Regeneron, a leading biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.As the owner and president of Solution Systems, Inc., I also provide methodology, process, and project management for companies that require compliance remediation, technology transfer, and facility delivery. I have successfully led and executed multiple projects in high-visibility and complex situations, such as consent decree, warning letter, and form 483 remediation efforts. My specialties include pharmaceutical project management, quality remediation, new product launch, global quality initiatives, and facility commissioning through licensure.