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
マスターコントロール バリデーションサービス&ソリューション グループマネージャー、ソフトウェアバリデーションエキスパート

Louis Rutledgeは、プロセス工学、 文書管理 導入、ソフトウェア 構成管理 、品質マネジメントシステムにおいて、ほぼ20年の経験を有しています。米国防総省に勤務していたほか、医療業界や一般製造業界、通信業界でも勤務経験があります。3Com/US Robotics Residential Productsの製品&リリース部門のディレクター兼品質システムマネージャーとして、ライフサイクル開発や製品実現、設計チーム管理を担当し、複数の製品ラインで、200を超えるプロジェクトのリリースを管理しました。2001年にマスターコントロールに入社以来、Rutledgeは、米国やカナダ、英国の150を超えるお客様を対象としたソフトウェア実装及びバリデーションプロジェクトを指揮してきました。また、 ISO 9001 :1994、ISO 9001:2000、ISO13485、TL9000、QS9000、21 CFR Part 11、210-211、606、820、Q7A、ソフトウェア開発の能力モデル(CMM/CMMI)、ANSI、IEEE、BABT仕様などを含む、バリデーションプロトコル開発にも携わっています。米海軍で電子工学の技術学位を取得したほか、 ISO 9000 及びTL9000品質規格のリード監査員資格を有しています。また、American Society for QualityやISPE、CMU SEI SEPGコミュニティの活動的なメンバーでもあります。

Oliver N. Wolf

生物科学や情報テクノロジー、経営管理の教育を受けたOliver Wolfは、 医薬品及びソフトウェア業界の情報システムやコンピューターのバリデーションにおいて、10年を超える経験を有しています。Cephalon Inc.(旧Anesta Corp.)でキャリアをスタートさせたWolfは、最初に検査技師として勤務し、後にITマネージャーとなりました。また、Pfizer社やAmgen社、イーライリリー社において、自動エンジニアリングやソフトウェアバリデーション、プロジェクト管理に関するコンサルティングを担当しました。2004年にマスターコントロールに入社し、コンピューターバリデーションコンサルタントとして勤務。その後、プロダクトマネージャーになりました。Wolfはタフツ大学を極めて優秀な成績で卒業し、生物学と環境問題研究において2つの学士号を取得しています。また、ユタ大学では、情報テクノロジーに重点を置いたMBAも取得しています。データベース理論及び設計、ソフトウェア開発ライフサイクル方法論、プロジェクト管理、コンピューターバリデーション方法論、製薬工程においても専門知識を有しています。

MasterControl Product Manager / Blood and Biologics Expert

Rob Carpenterは、角膜/組織/血液バンク業界で16年を超える経験を有し、最近まで、オハイオ州デイトンにあるCommunity Blood Center/Community Tissue Servicesで、組織生成のディレクターを務めていました。在職中に医療機器を扱う様々な企業と連携し、13の新しい移植片を市場に投入しました。

Carpenterは、American Association of Tissue Banks(AATB)の活動的なメンバーとして、教育とプログラムの両方のコミュニティに所属しているほか、AATBのCertified Specialist Training and Review Courseのコースディレクターを務めています。 血液と組織に関する会議の議長としても全国的に有名です。


Steve Harrison
Product Owner, Auditing Solutions

Steve Harrison is a member of the product management team at MasterControl, where he is responsible for product design and roadmaps for the audit and studies software. He works closely with the engineering and QA teams, as well as with existing and new customers, to develop solutions.

In 2007, Harrison took over as development manager for the European division of MasterControl. He then moved to the product management team in 2013. 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.

Harrison began his career as a software engineer with several small firms, building experience and a solid background in many aspects of technology. Prior to joining MasterControl, Harrison worked at AMG IT Systems, a small software company specializing in quality auditing solutions for tier one pharma companies.

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 sciences 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.