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. Chris is also a Valkit.ai Co-Founder. With deep expertise in SaaS, microservices, APIs, cloud infrastructure, and AI technologies, Chris blends technical acumen with strategic leadership to foster innovation and growth. Before co-founding 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 do not pretend to have the right answers, they ask the right questions.”
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”
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”