Mr. Grunbaum has over forty (40) years of experience as a business systems analyst, computer systems analyst and programmer, EDP audit and quality assurance professional and consultant. He is a recognized expert in the pharmaceutical industry, particularly in the areas of computerized systems, IT infrastructure, electronic records, regulatory training and the operations that support them, computer system validation, quality assurance, and compliance with 21 CFR part 11. He has written extensively on these subjects, won awards for best article, and has delivered numerous tutorials and training sessions to customers and industry groups. He has also provided compliance enforcement training to the FDA, helped to build quality infrastructures for life science companies and organizations that support them, prepared companies for customer audits and regulatory authority inspections, hosted customer audits and regulatory authority inspections and was asked to assist with field and fraud investigations. Furthermore, on behalf of the BioStrategy Partners/BioLaunch 611+ Keystone Innovation Zone organization, Mr. Grunbaum mentored early stage biotechnology and medical device companies.
Mr. Grunbaum was involved in organizational effectiveness, operational design, business process management, and computer systems design/development in the insurance and financial services industries, and designed a computer auditing model for the New Jersey practice of KPMG Peat Marwick. He also managed the computer auditing efforts for a major practice office of Coopers & Lybrand (now PriceWaterhouseCoopers), including all off-shore activities in support of a major pharmaceutical customer. He also assisted a copper and gold mining company in instituting disaster recovery policies and procedures off-shore in Irian Jaya province of Indonesia.
Prior to forming PSG, Len was President of META Solutions, Inc. responsible for managing the company and ensuring quality, timely and cost-effective delivery of its consulting services to life sciences companies. He oversaw and helped facilitate and implement the rapid growth of the company. Under his command, the company realized a five-fold revenue increase and a tripling of staff.
Additionally, in the early 1990’s, Mr. Grunbaum was Principal of his own company, LAG Consulting, focusing on IT operational consulting, technical writing, training and computer systems validation services.
Mr. Grunbaum received a Bachelor of Arts degree and a Masters of Business Administration “with Distinction” from Long Island University. He was also a member of the Editorial Advisory Board of the Institute of Validation Technology, an Adjunct Professor at Rutgers University and a program co-chair for BioStrategy Partners.