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Industry and Subject Matter Experts

Our industry experts bring a wealth of knowledge to the cause!

Lane Hirning
MasterControl Product Management Director, Pharmaceutical Industry Expert

Lane Hirning is a pharmacologist with extensive IT experience in the pharmaceutical industry. He started his career as a research scientist at NPS Pharmaceuticals Inc. After seven years, he moved into an IT function, serving over a span of 12 years as IT Manager, IT Director, and Senior Director of Research IT. Since joining MasterControl in 2006, Hirning has specialized in product development for the pharmaceutical industry, with emphasis on regulatory and other requirements for clinical teams. He has a bachelor’s degree in pharmacy from Idaho State University and a Ph.D. in pharmacology and toxicology from University of Arizona. He served as a post-doctoral fellow at the University of Chicago’s Department of Pharmacology and Physiological Sciences. Hirning actively participates in industry events, such as seminars and workshops on computer system validation, lab informatics, and pharmaceutical development.

Patricia Santos-Serrao, RAC
Senior Product Manager, Pharmaceuticals

Patricia Santos-Serrao, RAC, is a Life Sciences professional with almost two decades of experience in Regulatory Affairs and Clinical areas of the Pharmaceutical Industry.

Prior to joining MasterControl, Patricia held the position of Manager, Global Regulatory Solutions for QUMAS, a company specializing in quality and compliance management software for Life Sciences, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the Pharmaceutical Industry with a particular focus on submission document management for Regulatory Affairs, and Clinical Trial Master Files (CTMF) for Clinical.

She’s worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, both in Regulatory Affairs and Clinical. She’s assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling eCTDs, and other submission format filings worldwide. A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a Bachelor’s of Science degree in Business Administration. Patricia is a member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA). She has also earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB).

Matthew M. Lowe
Executive Vice President

Medical device expert Matt Lowe joined MasterControl in 2006. Since then, he has served MasterControl as a Product Manager and Senior Vice President. His career includes product development and product management at Ortho Development Corp. and Bard Access Systems. Lowe has successfully launched more than a dozen medical devices. He has five patents issued. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year post-market clinical study for orthopedic devices. Lowe has a bachelor's degree in mechanical engineering from the University of Utah and an MBA from Indiana University.

Louis Rutledge
MasterControl Manager of Validation Services and Solutions Group, Software Validation Expert

Louis Rutledge has almost two decades of experience in process engineering, document control implementation, software configuration management, and quality management systems. He has worked for the U.S. Department of Defense and in the medical, general manufacturing, and telecommunications industries. As Director and Quality Systems Manager of the Product and Release Department of 3Com / US Robotics Residential Products, he was responsible for the lifecycle development, product realization, design team management, and controlled release of more than 200 projects in multiple product lines. Since joining MasterControl in 2001, Rutledge has led software implementation and validation projects for more than 150 customers in the United States, Canada, and United Kingdom. His expertise includes validation protocol development, ISO 9001:1994, ISO 9001:2000, ISO13485, TL9000, QS9000, 21 CFR Parts 11, 210-211, 606, and 820, Q7A, the Capability Model (CMM/CMMI) for Software Development, as well as ANSI, IEEE, and BABT specifications. Rutledge has a technical degree in electronics from the U.S. Navy and lead auditor certifications for ISO 9000 and TL9000 quality standards. He is an active member of the American Society for Quality, ISPE, and CMU SEI SEPG communities.

Oliver N. Wolf
MasterControl Product Manager, Pharmaceutical Manufacturing Expert

Trained in biological sciences, information technology, and business administration, Oliver Wolf has more than a decade of experience in information systems and computer validation in the pharmaceutical and software industries. He started his career at Cephalon Inc. (formerly Anesta Corp.), where he served first as a laboratory technician, and eventually, as IT manager. He held several consulting positions at Pfizer, Amgen, and Eli Lilly, in automation engineering, software validation, and project management. He joined MasterControl in 2004, first as a computer validation consultant, and then as a product manager. Wolf earned a double bachelor’s degree in biology and environmental studies magna cum laude from Tufts University. He has an MBA, with an emphasis in information technology, from the University of Utah. His expertise includes database theory and design, software development lifecycle methodologies, project management, computer validation methodologies, and pharmaceutical manufacturing processes.

Rob Carpenter
MasterControl Product Manager / Blood and Biologics Expert

Rob Carpenter has worked more than 16 years in the eye, tissue and blood banking industry, most recently as the Director of Tissue Processing for Community Blood Center/Community Tissue Services in Dayton, Ohio. During his tenure, he worked with various medical device companies to bring thirteen new grafts to market.

As an active member of American Association of Tissue Banks (AATB), Carpenter serves on both the Education and Program Committees and as a course director for the AATB’s Certified Specialist Training and Review Course. He is a recognized speaker at blood and tissue conferences across the country.

Carpenter holds a Bachelor of Science degree in Biological Sciences from the University of Cincinnati and a certificate in Project Management from Xavier University.

Steve Harrison
Product Manager, Auditing Solutions

Steve Harrison has over 20 years' experience in the IT industry and has worked in a number of fields including legal, telecommunications, electronic transaction processing, and quality assurance. He started his career as a software engineer with several small firms, gaining exposure and building experience in many aspects of technology and industry to form a solid background in IT. Harrison joined AMG IT Systems in 2005, a small software house which specialized in Quality Auditing solutions for Tier One Pharma companies. AMG was acquired by MasterControl in 2007 and Harrison took over as Development Manager for the European division of MasterControl. He moved into the Product Management team in 2013 and is currently the Technical Product Manager for all Auditing solutions.

Alex Butler
Product Manager, Life Science Applications (LS APPs)

As product manager of life science applications (LS APPs), Alex Butler is responsible for developing and/or improving several MasterControl QMS solutions, including MasterControl Complaints, Bill of Materials (BOM), Projects, Risk and PDM Connector. Prior to joining MasterControl, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit™ Class II Corrector. With more than four years of direct medical device experience, as well as a deep understanding of the FDA’s submission process and audit procedures, Butler is a welcome addition to the MasterControl team.

Mickey Garcia
Director, Medical Device Industry Solutions

As the segment manager of MasterControl’s medical devices product management group, Mickey Garcia guides the development of solutions that offer MasterControl medical device customers the fastest path to market and success. He has more than twenty years of experience in the life science and software industries.

Garcia began his career working in manufacturing operations and systems engineering at Johnson & Johnson, where he was responsible for designing and validating automated production systems and leading Six Sigma Black Belt quality improvement projects. More recently, he led the product strategy efforts for a range of QMS, ECM, MES and PLM software companies serving the life sciences.

Garcia holds a bachelor’s degree in mechanical engineering from the University of Florida and an MBA from Stanford University.

Rob Thomas
Director of CX/UX/UI (Customer and User Experience), MasterControl

Rob Thomas is director of CX/UX/UI at MasterControl, where his responsibilities include: managing the end-to-end user experience across all user touch points; defining the User Interface (UI) or Graphical User Interface (GUI) standards and best practices for all digital products and services; overseeing Section 508 compliance and accessibility initiatives; and serving as the product manager for the MasterControl customer website.

Thomas has more than 17 years of experience in user experience design and leadership, software design and development, product management and process improvement. Prior to joining MasterControl, Thomas held many leadership positions, including director of user experience for the LDS Church, director of product development at Westhost and Internet manager for Melaleuca. He was also founder and CEO of Stellar Communications, an ISP business in Idaho and Utah. Thomas’s breadth of experience and knowledge of user needs has helped transform many organizations’ systems development lifecycle (SDLC) into optimal user-centric processes.

Thomas earned his bachelor’s degree in graphic design, with a minor in marketing, at the University of Idaho.

Terrance Holbrook
Senior Product Manager, MasterControl

Terrance Holbrook is a Senior Product Manager at MasterControl, where his responsibilities include product design and development and market research for software features and functionality. He has 20 years of industry experience in manufacturing fields and seven years in product development of medical devices.

Holbrook is a certified Six Sigma Black Belt and ISO 9001:2008 lead auditor and is also certified in lean manufacturing and total quality management. A member of the Project Management Institute, Holbrook holds a bachelor’s degree in business administration and an MBA with a concentration in international business.