Our Leadership Team
The leaders and primary decision-makers of Valkit.ai
Hugh Devine
Chief Executive Officer
Hugh Devine has 20 years' experience in the Life Science and Health IT compliance industry. Trained in US & EU IT regulatory requirements with significant experience in Computer Software Assurance and IT Governance, as well as the commercialisation of Software as a Service applications for the Life Science and Health IT sectors (inclusive of HIPAA and GDPR compliance). Hugh has co-founded and led multiple high-growth start-ups in both the US and EU from launch to company exit and has extensive experience in strategic planning and partnerships to help develop and resource customer solutions. “You miss 100 percent of the shots you don't take.”
Stephen Ferrell
Chief Product Officer
Steve Ferrell is a visionary leader in IT governance, software assurance, and cybersecurity, with over 20 years of experience advancing innovation in the life sciences and healthcare industries. As the Chief Product Officer at Valkit.ai, Steve drives the strategic vision, development, and delivery of cutting-edge AI-powered solutions that empower organizations to streamline compliance and optimize operational efficiency. His extensive expertise in product leadership and regulatory frameworks ensures Valkit.ai remains a trusted leader in compliance technology. In addition to his role at Valkit.ai, Steve serves as Chief Strategy Officer at Strike Graph, a global Compliance Posture Management (CPM) platform, and is the co-chair of GAMP Americas, as well as a member of the ISPE GAMP Global Steering Committee. Steve's contributions to industry standards include leading the development of the second edition of ISPE's GAMP IT Infrastructure Control and Compliance Guide and contributing to GAMP 5, 2nd Edition. His unwavering commitment to excellence and thought leadership continues to shape the future of compliance innovation, enabling organizations worldwide to navigate regulatory complexities with confidence. “Flowers are like butterflies, you can eat them, but should you?”
Chris Ferrell
Chief Technology Officer
Chris Ferrell brings over 20 years of experience leading technical innovation, architecting scalable platforms, and empowering organizations to deliver results. As the Chief Technology Officer, Chris leads the vision and execution of all technical aspects of Valkit.ai. With deep expertise in SaaS, microservices, APIs, cloud infrastructure, and AI technologies, Chris blends technical acumen with strategic leadership to foster innovation and growth. In addition to his role at Valkit.ai, Chris held strategic technical roles at top SaaS companies, including Contentful and Acquia, and helped to lead the development of internal learning platforms at Nike. In past roles, he advised Fortune 500 organizations, including Charles Schwab, AT&T, and Roche, on architecting and scaling enterprise solutions. He has also led targeted growth strategies founded in value-led product positioning to maximize ARR. Chris has previously founded two other companies, an AI-enabled SaaS tool for value-led sales strategies and a professional services firm for enterprise SaaS solutions. “Leaders don't pretend to have the right answers, they ask the right questions.”
Lisa Silva
Interim Chief Marketing Officer
Lisa is a strategic marketing executive with over 20 years of experience driving growth and transformation in SaaS, cybersecurity, and compliance software companies. As the Interim Chief Marketing Officer at Valkit.ai, Lisa leads the company's go-to-market strategy, demand generation, and brand positioning during a critical phase of expansion and market penetration. Lisa brings a proven track record of scaling marketing operations and delivering measurable results. Most recently, she served as Chief Marketing Officer at Channel Program, where she led comprehensive marketing strategies for a B2B SaaS platform. Prior to that, she was Chief Revenue Officer at WorkBetterNow, where she oversaw both marketing and sales operations to drive revenue growth and market expansion. Her most significant impact came during her five-year tenure as Vice President of Marketing at INKY Technology, where she joined as employee number 8 and built the marketing function from the ground up. Under her leadership, INKY achieved 100% year-over-year sales growth through strategic demand generation, brand positioning, and omnichannel marketing campaigns. She successfully managed comprehensive marketing strategies including content creation, SEO optimization, paid advertising, email marketing, and conversion rate optimization. Lisa's expertise extends to regulated industries, having served as Vice President of Marketing & Privacy Officer at ByteGrid, where she managed marketing for a national data center and managed cloud hosting services firm specializing in healthcare and pharmaceutical clients. During her tenure, she achieved a 500% growth rate in lead generation and implemented account-based marketing strategies for regulated organizations. "Lisa is a powerhouse marketing executive with a deep understanding of complex B2B sales cycles," said Hugh Devine, CEO at Valkit.ai. "Having worked with her previously, I know firsthand how effective she is in building demand and delivering results, especially in SaaS and compliance-driven markets. Her leadership will be critical as we scale." Lisa's strategic approach combines data-driven decision making with creative brand development, enabling her to build high-performing marketing teams and establish market leadership positions. Her experience spans brand strategy, product marketing, demand generation, digital and content marketing, public relations, and sales enablement across multiple technology sectors. "I'm excited to join Valkit.ai at such a critical juncture," said Lisa. "This role allows me to apply both hands-on operational leadership and strategic advisory insight. I look forward to partnering with the team to drive momentum and position Valkit.ai as a category leader in digital validation." Lisa's appointment comes as Valkit.ai continues to expand its market presence and enhance its product offerings, positioning the company for accelerated growth in the life sciences compliance technology sector.
Advisory Board
Industry experts and advisors guiding our vision and growth
Dr Paul Campbell
Chief Regulatory Officer at HealthAI
Dr Paul Campbell is the Chief Regulatory Officer at HealthAI, bringing extensive expertise in healthcare, technology, and regulation to this global agency for responsible AI in health. Previously, he served as Head of Software and AI at the MHRA, where he led transformative initiatives like the Software and AI Medical Device Change Programme and the AI Airlock regulatory sandbox. With a distinguished clinical career in medicine, an initial career in Pharmacy, and a graduate of the NHS Digital Academy's first cohort, Paul is a respected leader in digital health and medical device regulation. “Better to aim for the stars and miss than to aim for mediocrity and hit it”
Michael Rutherford
Principal at Rutherford Consulting, LLC
Michael Rutherford is a retired pharmaceutical industry quality professional with almost 37 years of experience. He most recently served as the Interim President & CEO of ISPE and the ISPE Foundation from September 2024 to January 2025. In November 2023, he retired from Syneos Health as Executive Director, Quality Assurance, Computer Systems Quality and Data Integrity where he was responsible globally for computer systems quality and data integrity. He previously retired from Eli Lilly and Company at the end 2017 where he held numerous technical, administrative, and operational leadership roles within the Laboratory, Quality, and Medicines Development Unit. Mike is Principal at Rutherford Consulting, LLC, formed in May 2024. Mike is recognized as a global technical expert in ER/ES, data integrity, computer systems validation and quality, as well as laboratory automation and laboratory informatics. Mike has been involved with ISPE and GAMP® since 2003. Prior to accepting the Interim President and CEO position, Mike served as Immediate Past Chair on the ISPE International Board Executive Committee and Board of Directors after serving as Board Chairman in 2022-2023. He also served as a Board member for the ISPE Foundation. He is a member and Past Chair of the GAMP CoP Global Steering Committee, a Past Chair of the GAMP Americas Steering Committee, a sponsor of numerous GAMP Special Interest Groups (SIGs), including those on Data Integrity and the Cloud, and a contributing author to numerous GAMP Guides and Good Practice Guides. He has organized and chaired numerous ISPE and GAMP related conferences and was the 2019 ISPE Annual Meeting Program Chair. Mike received the 2014 ISPE Max Seales Yonker Member of the Year Award and the 2016 ISPE Joseph X. Phillips Professional Achievement Award. Mike has a BS degree in Chemistry from Delaware Valley University, and an MS degree in Analytical Chemistry from the University of Kentucky.
Tommy O’Donnell
VP of Quality @ Rees Scientific
Tommy O'Donnell has spent over 20 years helping businesses in the Life Sciences and Healthcare industries stay compliant, organized, and ready for growth. An entrepreneur at heart, he’s built and scaled businesses, advised private equity groups, and streamlined operations with smart systems and technology. When he’s not simplifying processes, Tommy’s probably networking, brainstorming big ideas, or enjoying a good cup of coffee. “Business is like football—win with a game plan, adapt on the fly”
Brandi Stockton
Founder and Managing Partner of The Triality Group, LLC
Brandi Stockton is Founder and Managing Partner of The Triality Group, LLC, which provides technology, quality, regulatory, and compliance consulting services for the Life Sciences industry. She is an esteemed expert in computer systems quality and data integrity and a recognized thought leader for responsible use of AI in regulated areas of Life Sciences. Brandi holds several leadership roles within ISPE, serving as Vice President of ISPE Great Lakes Board of Directors, Chair of the GAMP Americas Steering Committee, Co-Lead of the GAMP Global Software Automation and Artificial Intelligence Special Interest Group, and a steering committee member of the ISPE GAMP Global CoP and the ISPE AI CoP. Brandi was a contributing author to several GAMP® Guidance Documents, including the GAMP® Records and Data Integrity Good Practice Guide: Data Integrity by Design, the GAMP® 5 2nd Edition, and the GAMP® Good Practice Guide: Computerized GCP Systems & Data 2nd Edition. “Don’t miss an opportunity to make connections. You never know the one person or conversation that can completely change the trajectory of your life.”
Ellen Huang
Owner @ Huang Biologics Consulting
Ellen Huang is a technical expert in regulatory, quality, and inspection within the life science industry. With a distinguished 12-year career at the Food and Drug Administration (FDA) and over seven years in industry, Ellen excels in conducting audits, ensuring inspection readiness, reviewing Biologics License Applications (BLA) and supplements, and developing corrective action plans that meet regulatory expectations. “Let’s reframe and move forward.”
Charlie Wakeham
Director, WakeUp to Quality Pty Ltd
Charlie Wakeham has specialized in GxP computerized systems quality and data integrity throughout her career. After 25+ years working for leading systems and software vendors across the Life Sciences industry, she now offers expert consultancy and training to regulated companies and vendors through her company WakeUp to Quality. An active member of ISPE for more than 20 years, Charlie has served on multiple ISPE and GAMP committees at the local, regional, and global levels. Among her current volunteer activities, she is the Chair of the 5,000-strong GAMP Community of Practice, a Director of the ISPE Australasia Affiliate Board, and a contributing author to nine published GAMP guides including the recent Second Edition of GAMP 5. “Innovation without validation is like a car without gas; it has great potential but no practical use.”
Eric Staib
Vice President, Corporate Quality, Syneos Health
Eric Staib is Vice President of Corporate Quality at Syneos Health. He has more than 25 years of pharmaceutical industry experience in various GXP areas, including direct experience and leadership for quality systems development/management, software quality engineering, information technology, and computer systems validation/assurance (CSV/CSA). He holds a BS in biology from James Madison University, an MS in quality assurance and regulatory affairs from Temple University, a graduate certificate in project management from Lehigh University, and an MBA in pharmaceutical management from Drexel University. Eric was a previous Chair of the GAMP Americas Steering Committee for ISPE, and currently chairs a Software Automation and Artificial Intelligence Special Interest Group (SIG), in addition to serving as Secretary of the AI CoP Steering Committee. He has presented at numerous industry conferences, in addition to having published and contributed to several concept papers, magazine and journal articles, and good practice guides; including the 2nd edition of GAMP5. Eric is also an ISPE recognized GAMP instructor. “Quality first, efficiency always”
Kristin Jones
President and CEO, Indiana Life Sciences Association
Kristin leads the Indiana Life Sciences Association, a primary networking, advocacy, and strategic planning resource for the sector. She also has 15 years of experience in international economic development in state and regional roles. Kristin is a past-chair of the Council of State Bioscience Associations (CSBA), an appointed member of the Indiana District Export Council (DEC), on the Indiana Small Business Development Centers advisory board, and has recently joined the advisory board for Heartland BioWorks, a biotech manufacturing Regional Tech Hub. “Nobody offers to show me the cool rock they found anymore. Adulthood is pretty dumb.”
Tanya Sharma
Co-Founder at Assurea
Tanya Sharma is the cofounder of Assurea LLC. Assurea is a quality compliance consulting firm that serves as a Quality and Computer System Validation delivery partner for fast-growing biotech and pharmaceutical clients. Assurea provides fractional services for startups and turnkey services for growing companies. Her expertise is in digital transformation and computer system validation for emerging technologies platforms and novel technologies. She is one of the contributing authors for the ISPE GAMP 2nd Edition and Co-Leading the Blockchain special interest group. Tanya has also started a campaign called RootingForYou to support more women and underrepresented ideas endorsed for their innovative ideas. “Are you looking for an experience in fact or in theory?”
Kevin Shea
Owner and Principal Consultant at Driftpin Consulting / Head of QA (fractional) at CellPort Software
Kevin Shea is a seasoned life sciences executive with over 20 years of experience spanning pharmaceutical, biotech, CRO, and technology sectors. For the past decade, he has focused on improving the tactical and strategic application of technology to improve clinical operations, enhance compliance, and drive organizational efficiency. For the past several years, this has included incorporation of AI-based solutions. Kevin’s expertise includes leading initiatives in development, QA, regulatory compliance, and change management, with a proven ability to solve complex workflow and technical challenges. As Principal Consultant at Driftpin Consulting, he is dedicated to delivering innovative, pragmatic solutions that align with the evolving demands of the life sciences industry. “AI is like a left-hand monkey wrench—if you don’t know how to use it, it’ll just make you look busy”
Laura Rose, PhD
Engagement Partner, Bruder Consulting & Venture Group
Dr. Laura Rose is an Engagement Partner at Bruder Consulting & Venture Group, bringing extensive regulatory expertise from her distinguished career at the U.S. Food and Drug Administration (FDA). During her tenure at FDA from 2015 to 2023, she most recently served as Assistant Director in the Division of Restorative and Repair Devices at the Center for Devices and Radiological Health (CDRH), where she oversaw the total product life cycle reviews of orthopedic devices and combination products. With a strong foundation in both regulatory affairs and biomedical engineering, Dr. Rose has comprehensive experience spanning pre-market, post-market, and compliance processes, including the review of clinical (GCP), nonclinical (GLP), and manufacturing (GMP) documentation. Her FDA career began as an ORISE Fellow at the Center for Drug Evaluation and Research (CDER) before progressing through roles of increasing responsibility at CDRH. Prior to her regulatory career, Dr. Rose conducted postdoctoral research at the Johns Hopkins School of Medicine's Institute for Cell Engineering. She holds a Ph.D. in Biomedical Engineering from the University of Alberta and a Bachelor of Science in Biochemistry from the University of British Columbia. In her current role at Bruder Consulting & Venture Group, Dr. Rose leverages her deep regulatory knowledge and technical expertise to guide clients through complex FDA processes and requirements.
Dr Fraser Smith
VP of Quality Assurance, Regulatory Affairs, and Safety Vigilance for Phillips Medisize
For over three decades Dr Fraser Smith has worked at the intersection of pharmaceutical science and medical device technologies, exploring where innovation, regulatory strategies, information systems and portfolio management can make significant impact in healthcare. Fraser is passionate about healthcare and how engineering, science, and technology intertwine to improve patient lives. He serves as the VP of Quality Assurance, Regulatory Affairs, and Safety Vigilance for Phillips Medisize, lives in the United Kingdom, and holds a B.Sc. (Hons) in Pharmacy, M.Sc. in Information Technology, and a doctorate in Pharmaceutical Medicine. Fraser brings a proven track record of successfully implementing system changes by building and leading high-performing, multidisciplinary teams of senior managers across global locations driven by fostering a culture of accountability, collaboration, impactful improvement, and excellence. He has been recognised as a strong and inspiring leader focused on enhancing quality and regulatory compliance by utilising GxP system-based approaches and data governance within clinical R&D, CRO, and commercial manufacturing organisations, to provide a superior customer journey, and helping accelerate access to new therapies, products and services. As AI healthcare regulation is still nascent with current regulatory models designed for locked healthcare solutions, Fraser’s industry expertise will help with AI model refinement allied to identifying new change management practices needed to account for implementing innovative, flexible, and evolving electronic solutions, to help bring the full benefits of AI to patients.