Life Science professional with regulatory, validation, qualification, QA, automation and operation expertise with Big Four consulting, pharmaceutical, automation and biotech companies. Proven success managing complex projects, analyzing processes to reduce risk and operating costs, creating plans to increase regulatory compliance and to improve safety. Experience includes planning and managing two major remediation projects, CSV oversight for equipment and utility validation at a new biotech manufacturing facility, creating and managing a project for the startup of IT, operations, DEA, QA and QC functions for a new pharmaceutical manufacturing facility. Areas of expertise:Project Management | Risk Management | Regulatory Compliance (FDA, DEA) | Continuous Improvement | Quality Assurance | Computer System Validation | System Testing | Compliance Remediation Programs | Staff Development | Corrective and Preventative Action Programs | Budgeting | Team Leadership | Training