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, product management director, is a pharmacologist with extensive IT experience in the pharmaceutical industry. Ever since he joined MasterControl in 2006, he has specialized in product development for the pharmaceutical, blood, and biologics industries, especially large-tier companies. He leads a dedicated team responsible for MasterControl’s software platform security.

Hirning began his career as a research scientist at NPS Pharmaceuticals Inc. for seven years. He then went on to serve various roles as an IT executive for 12 years. 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.

Patricia Santos-Serrao, RAC
RAC - Director, Pharmaceutical & Biologics, MasterControl Inc.

Patricia Santos-Serrao, RAC, has 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, where she helped drive the development, sales, marketing, and implementation of pharmaceutical industry solutions with a focus on submission document management for regulatory affairs and clinical trial master files.

She’s worked for several Tier 1 pharmaceutical companies in regulatory affairs and clinical, including Schering-Plough and Boehringer Ingelheim, and assisted companies in implementing electronic document management and submission solutions and in compiling eCTDs and other submission format filings. A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a bachelor’s degree in business administration. A member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA), Patricia 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

Matthew M. Lowe, executive vice president, is a mechanical engineer with over a dozen years of medical device experience in product development, product management, and regulatory compliance. He has successfully launched more than a dozen medical devices and has five patents issued. His regulatory compliance experience includes writing a 510(k) that was cleared by the FDA and managing a multisite, multiyear postmarket clinical study for orthopedic devices.

He joined MasterControl in 2006 as a product manager, rising to senior vice president after a few years and then executive vice president. As a medical device expert, he has written many articles in industry publications. He is the author of an e-book, “Convergence of Compliance and Technology: How Technology Has Changed Regulatory Compliance in the Past Decade,” published in 2016. He holds 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.

Alex Butler
Manager, Medical Device Solutions, MasterControl, Inc.

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 a director of product management at MasterControl, Mickey Garcia guides the development of solutions that offer MasterControl customers the fastest path to market and success. He has more than 20 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 Lean Six Sigma Black Belt and is certified in lean manufacturing and total quality management. A member of the Project Management Institute, Holbrook also holds a bachelor’s degree in business administration and an MBA with a concentration in international business.

David Hunter
Product Management Director

Dave Hunter, product management director, has more than two decades of experience in the software industry. He leads the development efforts for the company’s most popular modules: MasterControl Documents and MasterControl Training. He joined MasterControl in 2001 as a product manager responsible for several product lines.

Hunter’s extensive technology experience includes working for Microsoft, EDS, Intel, and TenFold. His expertise includes document control and training control for regulated environments, as well as food industry compliance. He has written articles on those topics for industry publications. He holds a bachelor’s degree in electrical engineering and an MBA from Brigham Young University.