Dr. Mark Willis

MDR and Compliance Willis QS Consulting

Dr. Mark R. Willis, LP.D


Dr. Willis is a seasoned Pharmaceuticals and Medical Device professional with over 20 years’ experience in the industry.  He has extensive experience leading global regulatory programs as both a project manager (PMP) and as a software quality engineer participant (certified SQE and Quality Auditor).  With a doctorate in law and public policy as well as a participant in construction of the recent ISO 9001 update, Mark has provided consultation on how to “right size” an organizations regulatory compliance so that their software implementations are able to meet their needs without distracting from daily operations.  Dr. Willis supported medical device and pharmaceutical corporations through U.S. FDA and EMA audits acting as the lead contact as well as managing the site “war room”.  Beyond product implementation and audits, Dr. Willis has supported corporations in compliance of regulations such as REACH, RoHS, Corporate Social Responsibility, etc. 


As a professor at Northeastern University and at Massachusetts College of Pharmacy and Health Sciences, Mark has been training and mentoring the next generation of project managers with a concentration on execution within a regulated environment as well as health economics.  Mark is currently working with global health authority agencies as well as the UN and USAID to conduct research for technological solutions like Blockchain and PCIDs to secure the pharmaceutical supply chain and is the author of “Counterfeit Pharmaceuticals: Are the U.S. Consumers Aware of the Potential Risks?” 




Doctorate of Law and Public Policy

Dissertation: Counterfeit Pharmaceuticals: Are the U.S. consumers aware of the risk?

July 2018


Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

Sigma Epsilon Rho Honors Society

May 2009


Bachelors of Science Degree in Finance/Economics

June 1999


Professional Items of Note

Presenter: Drug Information Association (DIA) conference 2014 – San Diego, CA

Presenter: Project Management Education Forum 2015 – Boston, MA

Lecturer: Harvard University School of Business (2014)

Speaker: NAAAP's 2016 National Leadership Conference – Boston, MA

Speaker: IQPC’s 2017 Pharmaceutical Serialisation & Traceability Conference – Vienna, Austria

Guest Speaker: 8th Annual Pharma Anti-Counterfeiting, Serialisation, Track & Trace Conference – London, England

Keynote Speaker: IQPC’s 2018 Pharmaceutical Serialisation & Traceability Conference – Zurich, Switzerland

Keynote Speaker: IQPC’s 2018 Pharmaceutical Traceability Conference – Philadelphia, PA, US

Keynote Speaker: IQPC’s 2019 Pharmaceutical Brand Protection & Traceability Conference – Zurich, Switzerland

Keynote Speaker: IQPC’s 2020 Pharmaceutical Brand Protection & Traceability Conference – Prague, Czech Rep

Good Will Ambassador: Fight the Fakes Organization

Brazilian Business Visa – 5 years, multiple entry (2015)

Chinese Business Visa – 10 years, multiple entry (2015)


Focus Day

Friday, December 4th, 2020

4:00 PM Project Management and Risk & Quality Assessment Tools to Enable Healthcare Delivery Success

  • Leveraging project management approaches to VA rollouts for measured success
  • Navigating challenge regulatory environment
  • Applications across healthcare environments 

Check out the incredible speaker line-up to see who will be joining Mark Willis.

Download The Latest Agenda