Senior Vice President Quality Assurance

P&G

Chief Quality Officer

Sanofi

Vice President, Global Quality & Safety

Glaukos Corporation

Vice President of Quality

Purolite

Vice President, Research and Development Quality

CSL Behring

SVP, Chief Quality and Regulatory Officer

GE Healthcare

Senior Vice President, Global Quality and Regulatory Affairs

Zimmer Biomet

Vice President of Quality

STERIS

Vice President and Chief Quality Officer

Johnson & Johnson

Senior Vice President, Supply Chain Global Technical Organization

Ecolab

Head of Global Quality

AstraZeneca

Senior Vice President of Global Quality

Seqirus

Senior Vice President Quality, HSE and Technical Services

Elanco

CEO and President

Pathway for Patient Health

[Connect via LinkedIn] Phillips founded Pathway for Patient Health in 2018, and leads cultural, quality and supply chain initiatives with regulators and industry professionals for the betterment of patient health around the world. Phillips is a frequently invited speaker for major industry association conferences across the country each year, including the PDA/FDA Joint Regulatory Conference, AdvaMed Medtech Conference, Cold Chain Global Forum, USP, IPEC, and the FDA’s own Association of Food and Drug Officials.

In 2008, Phillips founded, Xavier Health at Xavier University. In this role, Phillips was asked to co-lead with FDA the CDRH Case for Quality metrics initiative from 2014-2016, which culminated in work that continues to support the Case for Quality program. She led the Good Supply Practices (GSP) initiative with the FDA Office of the Commissioner, CDER, pharmaceutical and medical device professionals, and suppliers, which has been published for global industry adoption. Additionally, Phillips founded the FDA/Xavier PharmaLink Conference, FDA/Xavier MedCon Conference, AI Summit and Combination Products Summit for global regulators and industry professionals.

Phillips began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She has expertise in leading FDA inspections and readiness, quality, analytical testing and validation, supply chain, stability program management, process validation, manufacturing, and packaging operations.

Phillips holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.

Director of Corporate Programs

Pathway for Patient Health

[Connect via LinkedIn] Michelle Rich is the Director of Corporate Programs for Pathway for Patient Health. Rich supports the success of the corporate members who are funding the Quality Science Education Program that is given to every participating student and university at no cost. In this role, Michelle works with the corporate community to engage industry members with the students through mentorship, volunteer grading and teaching. Additionally, Michelle supports companies in their implementation of the Quality Science Education for talent acquisition and talent development. With so much to take advantage of, Rich helps connect people across the global enterprise to ensure companies are able to make the most of their membership.

Rich has over 25 years of experience in the pharmaceutical industry, and prior to joining Pathway, served as the Associate Director of Program Development at Xavier Health, Xavier University. In this role, Rich led initiatives with FDA officials, global regulators and pharmaceutical and medical device professionals. Her passion for the pharmaceutical industry began as a Territory Manager for Parke-Davis in 1996. Prior to coming to Xavier University, she spent over eight years with a privately-held manufacturing company that supplied the pharmaceutical and medical device industry with temperature monitoring solutions, giving her insight into the complexity of supply chain and experience in working with cross functional teams to implement solutions.

Rich holds a B.S. in Organizational Communication from Ohio University.

Director of University Relations and Enrollment

Pathway for Patient Health

[Connect via LinkedIn] Hinkle joined Pathway for Patient Health in 2019, and is the Director of University Relations and Enrollment for the Quality Science Education Program. Hinkle engages global universities, and works with students to approve their enrollment and course requirements for the QSE certification. Hinkle has over 30 years of experience in both the pharmaceutical and medical device arenas, from preclinical research through PMA submissions. In addition to her role at Pathway, Hinkle serves as the Quality Manager for Clinical Research Consultants. She assists in design, implementation and management of corporate Quality Systems, corporate training programs, and performs internal and external compliance audits in accordance with applicable regulations. Hinkle worked with the Vice-President of Clinical and Regulatory Affairs and leadership team to overhaul a Fortune 50 company Quality System, developed the Investigator-Initiated clinical study program, and implemented clinical cycle time and resulting process improvements.

Prior to Clinical Research Consultants, Hinkle worked for Procter & Gamble, and was responsible for leading the Global OTC Clinical Process team, working with the international organization to merge clinical programs. She facilitated the design and opening of its Analgesic, Respiratory, and G.I. clinical research facility; managed the Key Element Tracking Performance for the Development organization; managed the Behavioral Pharmacology Laboratory, along with designing, scheduling, and conducting operant and non-operant pre-clinical studies to determine behavioral and nervous system effects of drugs; and managed the Microbial robotics/automation project.

Hinkle holds a B.S. degree in Zoology from Miami University.

Chief Technology Officer

Pathway for Patient Health

[Connect via LinkedIn] Joyce joined Pathway for Patient Health in 2019, where she supports the success of each student and corporate member by establishing a corporate technology strategy. She has developed the Pathway Hiring Portal (which connects students to industry opportunities), develops system integrations, and data management processes. Joyce serves as the technical support expert for students and industry professionals engage with Pathway. Joyce brings diverse experience in finance, human resources, compliance, and business operations.

Joyce has served as Adjunct Professor of Economics at St. Joseph’s University and in a volunteer capacity as Treasurer for a non-profit organization in the fine arts. Joyce was a Senior Financial Analyst for The Federal Reserve Bank of Philadelphia, during which, she was responsible for reporting the bank’s annual expense budget and presentation development for bank officers. She held a management role for Prudential Insurance where she oversaw customer service and claim support functions.

Joyce holds a BA in Mathematics from La Salle University and an MBA from the Villanova University School of Business.

Director of Student Affairs

Pathway for Patient Health

[Connect via LinkedIn] Beebe joined Pathway in 2021, where she establishes the Quality Science Education courses in the learning management system each semester, manages student progress throughout the courses, runs the mentorship program, engages industry volunteers, and maintains student data. Beebe’s diverse background in data and systems enables her to constantly assess student experiences in the program, evaluate how to continually improve, and revise the processes and systems needed to increase student success.

Beebe holds a BS in Business from Emmanuel College and an MBA from Piedmont College.

Chief Scientific Officer

Pathway for Patient Health

[Connect via LinkedIn] Hoste joins Pathway for Patient Health as the Chief Scientific Officer, who leads the development of scientific content and learning. Hoste is also the Pathway Associate Professor for all 3 Quality Science Education courses, and has over 25 years of experience in the medical device & combination products industry and FDA. Hoste was instrumental in the development of several classes in the Product Development and Validation course and Risk and Failure Analysis course. In addition to teaching the Pathway courses, Hoste is also works part time as a Sr. Principal Consultant at Kymanox and is active on several international standards committees for medical devices.

Formerly, Hoste worked as Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and as reviewer within the Center for Drug Evaluation and Research (CDER). At the FDA, she led reviews of Human Factors data for medical device premarket submissions through 510(k), PMA and De Novo pathways, combination products through NDA, BLA, ANDA pathways, as well as data to support IND and IDE requests.

Hoste also has industry experience, working for several global medical device, IVD and combination product companies as in R&D as a Quality Engineer, Manager and Director. Over this time she worked within and directed project teams in all phases of product development from front end research to post-market support; as well as architecting process improvements for design controls, risk management, requirements management, software validation, system verification/validation and the incorporation of human factors and usability into overall product development processes.

Hoste holds a B.S. in Mechanical Engineering from the University of Toledo; an M.S. in Management from Mount Vernon Nazarene University; and an M.S. in Cognitive Systems Engineering from the Ohio State University.

Vice President, Global Quality, Regulatory and Clinical

Stryker

Senior Vice President, Global Quality Compliance

Merck

Vice President Quality, Safety and Regulatory Affairs

Fisher & Paykel Healthcare

Global Quality Officer

Takeda

Vice President, Global Quality Assurance and Regulatory Affairs

Thermo Fisher Scientific

Senior Vice President, Supply Americas

AstraZeneca

Vice President, Global Quality

Illumina