Michelle Bonn,
CEO and President
Michelle leads the company’s strategic direction and vision. She ensures the team is executing on corporate sales, operational improvements, and expanding service offerings. She’s committed and driven to building and maintaining a dynamic work culture.
Before acquiring Compliance Team, Michelle was the president and CEO of Guideline Medical, a profitable medical device regulatory consulting firm. Here she led international regulatory teams, ISO-13485 certifications, FDA regulatory clearances, FDA audits, and Health Canada medical device license registrations.
She has worked in China, Hong Kong, Singapore, Iceland, Italy, Mexico, and the United States. She is a certified, Six Sigma black belt and holds an MBA with a focus on strategic planning.
Michelle’s strength for building talented and effective teams, creates value for our customers while simultaneously moving the company’s growth plans forward.
Brian VanBibber,
Vice President of CQV Services
Brian has a strong history of success as a project manager leading a diverse portfolio of commissioning, qualification and validation projects. Brian’s subject matter expertise includes performing validation gap assessments and audits, data integrity assessments/remediation and facility, utility, equipment, VHP sterilization, steam sterilization, computer system and software validation. He has consistently demonstrated his technical ability to validate any facility, equipment, utility, and control system.
He is also experienced with validating analytical chemistry and microbiology laboratory equipment. Brian is a major contributor to the delivery of service excellence to our clients by applying his technical expertise and project management skills.
Regina Fullin,
Vice-President of RA/QA Consulting
Regina’s regulatory compliance consulting and project management experience includes advising and assisting clients with developing and implementing robust quality systems to achieve ever-increasing regulatory compliance, process control and product quality.
Regina’s subject matter expertise includes quality system auditing and development, CAPA/quality investigations, supply chain serialization compliance, data integrity, complaint handling and non-compliance remediation planning and validation. Regina writes relevant and meaningful articles to help manufacturers improve quality system policies and product quality and stay informed and current with regulations and industry trends. Regina is a RAPS (RAC) professional, Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and a Certified Manager of Quality-Organizational Excellence (CMQ-OE) with ASQ.
Patricia Rader,
Vice-President of Operations
Patricia’s extensive background in operations and project management ensures that our team has the tools and resources they need to be successful. Her unique skillset bridges the gaps between strategic initiatives and tactical efficiency.
Patricia has led a variety of projects from global clinical regulatory assurance to operational training for new facilities, as well as designing and implementing operational programs to improve efficiency in the consulting services sector. Prior to entering life-sciences consultancy, she designed and implemented global training programs supporting commercial launch of cutting-edge software products.
Dean Gionis,
Director of Business Development
Dean Gionis is a client-centric consultant with over 20 years of experience leading business development and sales operations. As Director of Business Development for Compliance Team, Dean has implemented initiatives to enhance our customer experience and account relationships.
Dean began his career in software sales which included experience with medical device and pharmaceutical manufacturers. Due to the highly technical nature of these mission-critical technologies, Dean has always employed a solutions-oriented sales methodology to ensure success for his clients.
He is a client advocate and enjoys helping to solve problems for his customers.
Dean graduated with a Bachelor of Science in Mathematics from SUNY Buffalo State University.