Award winning professional with experience partnering with multi-disciplinary teams in support of new product development projects, quality initiatives and process enhancements within the Medical Device, Pharmaceutical and Biologic environments. Proven leadership in directing multiple projects in parallel as well as at managing interdependencies, developing contingency plans and maintaining relationships with internal and external stakeholders. Proven mentor and change agent with a motivational management style, skilled at promoting continuous improvement, while responding and adapting to changing regulatory needs. Core Competency Areas➤Microbiology➤Quality Control➤Communication➤Team Leadership ➤Technical Writing➤Quality Assurance ➤Regulatory Affairs ➤Project Management➤Process Improvement➤Regulatory Guidelines ➤Testing Methodologies ➤Training & Development➤Cross-Functional Teams ➤Health Risk Assessment➤Laboratory Management➤New Product Development ➤ISO, AAMI, FDA Guidelines ➤Biological Safety Assessments