Expertise

Dr. Daniel Tisak is a Quality Director with extensive experience in the pharmaceutical, biotechnology and biomedical device industries.

• 25+ years of global experience in aeromedical, radiopharmaceutical, pharmaceutical, biotechnology and medical device industries and facilities, 15+ years in regulatory affairs.
• Has performed audit and validation services following GXP guidelines (GAMP, GCP, GLP, GcLP, GMP). GCP and GLP activities include routine study audits, inspection of testing facilities, verification of reports, verification of Quality Assurance Unit (QAU), verification of training, SOPs, and data integrity.
• Engineering team leader to execute $1.5 million average project backlog annually for the completion of validation, regulatory audits, project engineering and construction management, quality assurance and commissioning following multiple regulatory requirements. USGBC LEED AP, AEE Legend in Energy.
• Proven project management ability. Written and “hands on” executed approved quality and regulatory documents for inspections of pharmaceutical facilities, devices and controls. Worked with numerous corporate teams to provide quality and regulatory evaluations and strategies. Mentor of quality assurance, cross-functional teams and team building excellence.
• Subject matter expert and presenter, International Society of Pharmaceutical Engineering (ISPE) and the Association of Energy Engineers (AEE).