Deborah Miller

Deborah has more than 35 years as a quality and compliance champion working with laboratories regulated by CMS (CLIA) and industries regulated by the FDA . 

She has been an integral and successful contributor of compliance remediation for national and multinational pharmaceutical/ biotechnology/medical device companies reviewing, investigating, and correcting hundreds of records in short timelines.  She has leveraged her leadership experience in operations and compliance to tackle critical problems and develop and launch viable solutions and coach staff to continue effective, compliant operations. 

Deborah worked on a project to reinforce and refine the quality systems for an unproven CMO that was developing the process to manufacture a new personalized medicine vaccine.  She worked side by side with Quality Assurance, Quality Control and Manufacturing staff to establish and introduce QMS, GDP,  GMP , and GLP concepts and practices.  She has also been responsible for mentoring in manufacturing and quality assurance on writing procedures and work instructions, OOS, and deviation investigations and CAPA processes.. As a Quality Consultant , Deborah performed over 40 supplier and service provider compliance audits to include laboratory testing services for pharmaceutical, biotechnology, and medical device companies.