ABOUT

QMB is on a mission to help life science companies with the realization of effective, safe, and robust life science modalities and therapies that ensure high quality, personalized patient care. Our organization aspires to be the quality catalyst that fuels innovation from a compliance and regulatory standpoint. We understand and embody the mission of governing regulatory agencies to protect and promote public health while ensuring the safety and efficacy of biomedical therapies.

Our Leadership Team

Michel E Moravia

CEO, Founder

Michel E. Moravia, Chief Executive Officer, WBJ Top 40 Under 40: Product Executive and Quality Leader with 15+ years of experience working for Fortune 100 companies (AbbVie / Amgen / Novartis) in the pharmaceutical / medical device industry, where he successfully brought multiple prominent drugs / devices / combination products to market. At QMB, he is responsible for overall business strategy and operations. Michel is an ISO 13485:2016 Certified Lead Auditor and has instituted lean programs as a Master Black Belt that have realized savings of $6.5 million+ for Danaher Corporation. Michel fundamentally believes quality makes the human experience better. Michel holds a Master of Science in Product Design Engineering and an MBA in Health Sector Management from Boston University.

Thaina C. Roman

Operations, Co-Founder

Thaina C. Moravia-Roman, Chief Operating Officer, has 10+ years of experience within the medical industry. She provides primary care to 700+ patient panels while serving on a Governance Quality Committee. In addition, she has presented at multiple medical conferences and delivered presentations on heart disease risks and prevention within the African American Community, as well as De-escalation of Care modalities towards the end of life. At QMB, Thaina ensures collaboration between the Executive Leadership Team and assures policies from legal counsel and financial services meet business strategy. Thaina is passionate about quality as she knows it will mold a more sustainable future towards medical progress and innovation. Thaina holds a Master of Science Degree in Nursing from the MGH Institute of Health Professions.

Leonard Glatkowski, PhD

EVP, Regulatory and Customer Success

Leonard Glatkowski, EVP of Regulatory and Customer Success, Is a Quality, Regulatory, and clinical compliance professional with over 20 years of experience. Leonard is a Subject matter expert in Quality Management systems and Global compliance for class 1,2 and 3 Medical devices and Biologic/Pharmaceutical combination products. Leonard has worked with many large and mid-sized companies to bring devices to market on a global level; over the past 21 years, he has successfully created global parallel submission strategies and obtained 124 clearances of new product introduction and renewals throughout Asia, the Middle East, Australia, Canada, US FDA, South America as well as EU Member and Non-Member states. Leonard has also Remediated Quality and regulatory systems for compliance with MDSAP, MDR, and clearance of warning letters and consent decrees, as well as obtaining notified body certification through BSI and TUV for ISO certifications and renewals.

Christopher J Wallace

Lead Product Dev, Co-Founder

Christopher J Wallace, Chief Product Officer, has been with CVS/pharmacy for 10+ years and 15+ years of experience as a programmer. During his tenure as pharmacy manager, he increased turnover two-fold in less than a year while being awarded for excellence in customer service. At QMB, Chris is responsible for ensuring technology needs meet current and future business requirements while adhering to industry best practices for information security. Chris believes that the integration of quality-centric, user-friendly technology will improve patient outcomes while simultaneously reducing costs. Chris holds a Doctor of Pharmacy from Massachusetts College of Pharmacy and Health Sciences.

Henry Kim

CMO, Corporate Development

Henry Kim, Chief Marketing Officer, brings more than 33 years of experience in various medical device and biotech companies such as J&J’s DePuy Synthes, Zimmer Biomet, Baxter International, Hill Rom, and Cardinal Health to his role. Over the course of his career, he has developed and commercialized multiple products within the medical device space. He has previously led new product development teams and held leadership roles in global and US marketing, product management, as well as corporate strategy and business development. His most recent roles included leading corporate strategy, product management, and NPD at Dimension Inx a Chicago-based biotech startup focused on regenerative medicine and biomaterials. Henry holds a degree in Product/Industrial Design from Carnegie Mellon University, he has studied Healthcare Leadership and Healthcare Policy at Brown University, and Strategy at Cornell University's Johnson School of Business.

Sankeetha Selvarajah

General Counsel

Sankeetha Selvarajah is the Managing Attorney of Selvarajah Law P.C., a civil transactional firm located in Boston and New York. Her clients are within the cannabis, technology, real estate, food service, e-commerce sectors as well as, retail manufacturers. As a 6x Nationally awarded startup attorney, Sankeetha Selvarajah has more than a decade of legal and business consulting experience. She's passionate about creating better businesses by making law accessible to business owners. She is also the CEO of BiztoCO and STARTUP DOX (legal template company) and Zensei, LLC (exit-planning company). As outside general legal counsel to over 250 small businesses, she has also worked with startups as an advisor and strategist.

Our SaaS QualiVerse Advisory Board

QMB is seeking to transform the RA and QA landscape by developing a new AI driven platform to help companies and organizations navigate the Global Regulatory environment more efficiently. Laws, Regulations and Standards are evolving. Companies will have to react and adapt to new requirements for future submissions and compliance. Our Advisory Board is working with the executive team to help guide QMB in the development of our new platform, QualiVerse.

Arthur Lee

Arthur is a seasoned product executive with over two decades of experience in leading tech firms like IBM, Qlik, ETQ, and Tamr. He has a strong track record in launching successful SaaS products and driving revenue growth. Arthur has a passion for design thinking, customer-centric product development, and the transformative potential of AI across all industries. As a published thought leader and a compelling speaker, Arthur brings a blend of strategic leadership, data analytics expertise, and forward-thinking insights to the table.

Tanima Ghosh

Tanima is a rare leader with cross-functional subject matter expertise in both medical devices and combination drug-device systems for NAM, EMEA, LATAM and APAC. She brings her executive RA/QA leadership, agile R&D and operational “know-how” in total product life cycle management of complex hardware, software, platforms, and systems; used for measurement, detection, diagnosis, triage and treatment of various diseases and cancer. She has accelerated global market authorizations for combination products for mapping heart function and brain aging, cardiovascular diagnostics as well as tissue abnormality detection. As a multi-disciplined strategic advisor, Tanima has helped re-engineer, navigate, and simplify new product introduction business processes, develop and commercialize innovations including combination drug-device theranostic systems for nuclear medicine; computer-assisted surgical robots; cardiac PET imaging; MRI-based body composition analysis; radioisotope infusion sets; SaMD/SiMD plus novel AI/ML-enabled devices; telemedicine/telehealth remote patient monitoring platforms and pediatric expert systems using AI models. Ms.Ghosh is a graduate from McGill University (Physics) with two National Science and Engineering Research Council of Canada (NSERC) Industrial Research Fellowship Awards. She is a McGill certified Agile Scrum master, certified ISO-13485 lead auditor and she has completed the Executive Development Program from Queen’s School of Business. With numerous technical contributions to advance emerging hardware & software through patents & global regulatory submissions, Tanima has helped companies grow organically and through acquisitions as part of their SLT, IPO and M&A integration teams.

Christopher Crowley

Chris’s experience makes him uniquely suited to offer advisory services across a broad range of topics, with deep experience across all aspects of software and consulting: the software ‘sell side’, leading engineering and customer implementation teams for software startups; the software ‘buy side’, evaluating and implementing packages to deliver business value; the vendor-agnostic software ‘implementation side’, as leader of digital transformations across a variety of industries as an independent consultant. Building on his BS from MIT in Computer Science and MBA from Babson concentrating on Entrepreneurship.

John Brzezenski

John has a broad-based background spanning operating/executive management, advisory and private equity roles, helping numerous companies develop and execute successful growth strategies. He has developed perspective from “all sides of the table,” having been a Partner with a Strategy/Mergers and Acquisition advisory firm, senior operating executive, and member of the investment committee of a venture capital firm. John is currently a Partner with J. Locke & Co, a merchant banking group focused on equity investments and turnarounds of Special Situations i.e., distressed or underperforming companies. John graduated with honors from Harvard University with an AB in Economics, and holds an MBA from the Kellogg School at Northwestern University.

Nichole Riek

Nichole has 25+ years of Quality and Regulatory experience in both heavily regulated and research markets and has demonstrated results in building effective processes and systems using kaizen to drive value through Quality. Across her career, she has gotten regulatory clearances/approvals for multiple “first of a kind” products with experience in building and implementing worldwide regulatory strategies for Class I, II and III products. Nichole sees Quality as an often-under-utilized catalyst to drive change and value for an organization. Nichole holds a Bachelor of Science in Biomedical Engineering from Western New England College in Springfield, MA, U.S.A.

Darwin Shurig

Darwin understands that people are the greatest asset at any company and the key qualities that growth companies need to grow market share while enhancing their positive culture and team environment. He has a clinical background as a respiratory therapist of over 30 years including 12+ years of sales, business development, marketing and negotiations experience within medical device, diagnostics, distribution, ventilation, and sleep therapy, 8 years of sales leadership, 3 years of operations and extensive experience in negotiations and contract management before entering the entrepreneurial world of talent management.