Director, Pharma Client Support
Karen has more than 20 years' experience in the pharmaceutical and medical device industries and leads the Pharmaceutical Program Management practice within Regulatory Compliance Associates® Inc.
Prior to joining RCA, Karen held a variety of leadership roles within major pharmaceutical and contract manufacturing organizations that produced Active Pharmaceutical Ingredients (API) and finished dosage drug products. They include Catalent Pharma Solutions, Pfizer, Inc. and F. Hoffmann-La Roche.
With hands-on experience and extensive expertise managing complex projects, Karen can learn new processes and implement improvements using lean principles to drive operational efficiencies and reduce costs. Her major strengths are in consumer products and project management for the medical device, chemical, and pharmaceutical industries.
Karen has a Master of Business Administration and a Bachelor of Science in Chemistry from St. John Fisher College in Rochester, New York.
Director, Device Client Support
Mike Miller has more than 25 years' experience in quality management within the medical device industry. His areas of expertise include design control, corrective and preventive action (CAPA), product lifecycle, and change control.
At Regulatory Compliance Associates® Inc., Mike is responsible for client relations, resource selection and deployment, program budget monitoring, and program risk management. He leads RCA's internal team in developing quality systems compliant to ISO 9001 and has worked with an outside consulting team to support RCA in obtaining ISO 9001 certification.
Additionally, he is recognized for solving complex product issues and developing strong relationships with customers, manufacturers, and suppliers.
Formerly at Baxter, Mike holds a Master of Business Administration from DePaul University in Chicago, Illinois, and a Bachelor of Science in Industrial Technology from Southern Illinois University. Mike lives in Lake Villa, Illinois, not far from the Wisconsin border.