About

About

Meet LipaGroup

Mission & Values

We believe that smarter, effective knowledge practices lead to better medicines, better business performance, and employees doing their best work. Our work is grounded in:

Value to patients, and to the biopharma business
Integrity
Innovation, bringing best practices from across industries
Cross-functional collaboration

Our Approach
We help companies align KM with business and regulatory requirements including ICH Q10 (Pharmaceutical Quality System), ICH Q9(R1) (Quality Risk Management), ICH Q12 (Post-Approval Change Management), ISO 30401 (Knowledge Management Requirements).

Our proprietary RKI Cycle Framework has been featured in official ICH training, ISPE Good Practice Guides, PDA Technical Reports, and held up as a model framework by FDA, HPRA and other global regulatory agencies as a means to improve risk management, technology transfer, change management, risk-based decision-making, and overall PQS effectiveness.

We focus on leadership engagement, practical implementation, continuous improvement, and long-term sustainability.

We deliver value through mastery of a diverse toolkit including operational excellence, organizational change management, process management, risk management, systems thinking, digital, and organizational learning, using the right tool at the right time to diagnose and improve business performance.

Our Founder

Marty Lipa, PhD

Martin (Marty) Lipa has over 25 years of biopharmaceutical industry experience,
including over a decade in Knowledge Management (KM), and is a
US Department of State Fulbright Specialist Award recipient.

Marty is an independent industry consultant and regulatory advisor for pharmaceutical quality, risk & knowledge management, quality leadership, and business excellence. Marty was formerly Executive Director at Merck & Co. where he founded Merck’s KM program and delivered significant value enhancing quality system effectiveness, operational efficiency, and talent development. Marty is a Lean Six Sigma Black Belt, a certified process manager, and a skilled transformational change leader, with prior experience in technology, engineering, operations, digital, learning & development, supply chain, and validation.

Marty is an active member of the global KM and QRM community as a regular speaker, author, and volunteer, and has been recognized for his industry contributions, including by the US Fulbright Commission, ISPE as Member of the Year, Manufacturing Leadership Council for workplace innovation, and multiple times as a finalist/winner of the Article of the Year across multiple industry publications. In addition to broad support for the biopharmaceutical industry, Marty has consulted for NASA, Corning, the World Bank, Collins Aerospace, and has been an invited trainer for multiple regulatory agencies.

Marty has degrees in Pharmaceutical Regulatory Science (PhD), Chemical Engineering (MS), and Electrical Engineering. He adjunct faculty at TU Dublin where he co-advises in the PhD program in Pharmaceutical Regulatory Science, guest lectures at Columbia University, and is an editor of the Journal of Applied Pharmaceutical Regulatory Science.