My overall experience covers over 32 years in industry, which 22+ have been in the pharmaceutical/biotechnology business. My experience includes managing validation groups in support of both Drug Substance (bulk),Drug Product (Fill and Finish), and QC Laboratories buildings. Responsibilities included equipment/facilities, environmental, instruments, computer related systems, automation, sterilization, cleaning and process validation areas. Strong knowledge and hands-on experience in implementing and supporting 21 CFR 11 program and remediation activities.Offer a unique combination of management, leadership, technical expertise and hands on experience within Bio-pharmaceutical and technological driven industries. Accomplished leader, adept at developing and guiding diverse teams to delivers top performance. Competently handling multiple assignments while maintaining the highest emphasis on quality and compliance.During my overall pharmaceutical/biotechnology experience I actively participated in several regulatory inspections from different agencies (FDA, EMA, ANVISA, Health Canada, Turkish, Japan, and Mexico). As a validation management member we are active members of the preparatory sessions as well as during audits. Also I have been involved working on remediation activities and reporting requirements resulted from observations detected during these audits.Very energetic person who likes to work with people and groups with a lot of initiative and creativity. Works under minimum supervision.