Head of Corporate Quality Systems and Regulatory Affairs Sartorius Stedim North America Inc., Sartorius Corporation
Rick has been involved with quality in the pharmaceutical/biotech & medical device industry for more than 30 years. He holds a BS in Geology and MS in Industrial Management, both from SUNY Stony Brook in NY. Rick is also a Lean Six Sigma Green Belt through ASQ & a Regulatory Affairs certificate for Medical Devices through RAPS.
Rick is currently the Corporate Head of Quality Systems & Regulatory Affairs for Sartorius Stedim Biotech. Rick is responsible for overseeing the quality systems and regulatory affairs for all bioprocess operations.
Rick is knowledgeable regarding good manufacturing practices for both drugs and medical devices and the requirements for dealing with controlled substances. He also has experience in implementing ISO 9001 and ISO 17025 quality management systems and he is a certified lead auditor for ISO 13485.
Rick is also involved with contributing to the improvement of quality by being involved with several nonprofit quality organizations. He has held various local and divisional positions with the American Society for Quality. He is also one of the authors of a technical report published by ASQ called “Best Quality Practices for Biomedical Research in Drug Development” June 2012. He has also sat on the board of directors for ANAB, the notified body for ISO in the United States. Rick also sits on the board of directors for Rx-360 a global consortium for pharmaceutical companies and their key suppliers.
Check out the incredible speaker line-up to see who will be joining Rick.