Professional Compliance and Quality Systems DirectorDedicated, sharp-minded quality systems specialist with more than 19 years of expertise conducting regulatory efforts in the life science industry. With strategic ability, I develop and support compliance protocols in agreement with national and intercontinental disclosure reporting requirements and obligations. My thorough understanding of documentation and the implementation of systems assures comprehensiveness, maximizes efficiency and ensures proper business conduct. Passion for problem solving and proven track record in creating standardized methods to streamline processes, enhance effectiveness and reduce time management overhead. I have been recognized as a meticulous thinker due to my implementation of quality controls and system validations. I have outstanding skills monitoring and executing investigative analysis, writing standard operation procedures, and performing internal, external and supplier compliance audits, as well as designing system validation protocols. My ability to work with the executive management team and communicate quality system performance indicators displays my skill in implementing problem solving, failure models and enhances our overall quality program.I have demonstrated the ability to train and manage teams in quality assurance, as well as evaluate, examine and address compliance issues. Client demographic:Quality Management, Process Improvement, Facilities Management, EH&S, Operations Management, Risk Management, Process Engineering, Project Managers, Auditing, Compliance, Supplier DevelopmentAreas of focus: Biotechnology, Pharmaceutical, ISO 9000, HIPPA, cGMP, GDP, GLP, DNA and RNA isolation, Reverse Transcription, PCR Mixtures, Equipment Validation, Inventory Management, Design SOP systems, Disaster Recovery, Specimen storage and handling, Tecan, Clinical Trials, Quality Control, Safety