Education Programs

Speaker Bios:
Theresa McCarthy, Past Chair, American Society of Quality Boston Section (2009-2010)
Theresa McCarthy is the Past Chair of the American Society of Quality Boston Section (2009 – 2010) and actively involved on the Education Committee. She is an experienced RABQSA Lead Auditor, Project Manager and Trainer.

She has developed and delivered compliance based workshops for the National Institute of Standards and Technology through Merrimack College, the Massachusetts and New Hampshire Manufacturing Extension Partnerships (MASSMEP and NHMEP), Information Mapping and Perry Johnson Inc.
Theresa is a Senior Compliance Specialist for a Pfizer (formerly Wyeth BioTech) where she conducts internal and external audits.

Kristin Murray, Senior Manager GCMC Regulatory Affairs, Pfizer
Ms. Murray is a Senior Manager in the GCMC Regulatory Affairs department and oversees global regulatory submissions for both investigational and commercial products within Pfizer Biotech. Ms. Murray has provided the regulatory leadership for the execution of Quality Risk Management across Pfizer’s Biotech sites. Her risk management experience includes efforts in the areas of facility design, operations and controls, process containment, cross-contamination prevention and control, as well as multi-product/multi-host considerations. Ms. Murray frequently represents Pfizer at conferences, community symposia, and within industry working groups.

Ms. Murray received a BS in Biochemistry from Bates College and a Master of Science degree in Biochemistry from Harvard University.

Randy Perez, PhD, Director, IT Risk Management and Compliance, Novartis Pharmaceuticals
Dr. Perez currently holds the position of Director, IT Risk Management and Compliance for Novartis Pharmaceuticals. His responsibilities at Novartis include a wide range of IT Compliance issues, such as GxP, Sarbanes-Oxley, and data privacy. He serves on several global Novartis teams dealing with computer systems compliance issues, and has authored many of the firm's global GxP compliance policies. During his 27-year tenure at Novartis, he has developed a broad range of experience. Prior to his current position he worked as a chemistry group leader in process research, managed a chemical manufacturing process validation initiative, and ran both a GMP training program and a QA validation group for pharmaceutical operations.

Dr. Perez was a member of the PhRMA Computer Systems Validation Committee from 1995-1999, and was instrumental in the formation of GAMP Americas when that group started in 2000. From 2002-2008 he was Chairman of GAMP Americas and he has been a member of the global GAMP® Council since 2002. He initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice Guide that was published in 2005, and was part of the core team that led the development of GAMP® 5, published in 2008. Dr. Perez has been a speaker and a course leader at numerous conferences in the US and Europe, and has been published in industry journals and textbooks. In 2005 he was elected to the ISPE International Board of Directors, most recently serving as Treasurer.

Stephen Reich, Risk Management Principal, Pfizer Global Quality
In his role as Risk Management Principal, Mr. Reich leads Pfizer’s Quality Risk Management community of practice, and facilitates development and harmonization of Quality Risk Management best practices across a global network of locations. He routinely provides organizational leadership, project management, training, and facilitation for risk management programs and initiatives.

Mr. Reich’s leadership of pharmaceutical risk-based initiatives has included diverse topic areas such as quality systems, multiproduct facilities, manufacturing operations, engineering & maintenance, finished product AQLs and packaging, and the integration of QRM with Lean Six Sigma operational excellence (OE) initiatives.

Mr. Reich is a graduate of Cornell University with a B.S. in Chemical Engineering and also holds a Master’s degree in Quality Assurance and Regulatory Affairs from Temple University.