Women Leading Validation Quality Panel – Moving the Needle

ProcellaRX and KENX are excited to bring 6 powerhouse women to the table for KENX’s Women Leading Validation Quality Panel – Moving the Needle.

Dori Gonzalez-Acevedo will join fellow Chief members:

Denise Dajles – Senior VP of R&D, Regulatory and Quality at Sientra
Catherine Hall – VP of Clinical Innovation and Quality at EndPoint Clinical
Elena Mack – VP, Global Manufacturing Quality, Olympus Corporation
Dinamarie Stefani – Head of Quality at Verily
Katie Terry – President & Founder of KT Consulting
Ann Vu – Senior VP of Quality, Regulatory and Clinical at ZimVie

Our discussion during the panel, will focus on moving the needle in 3 key areas – the overall industry 4.0 shift, the impact of COVID-19 in every industry, and how the Life Sciences are unique in how the Industry 4.0 shift is occurring within these organizations (Pharma 4.0, Manufacturing 4.0, and Validation 4.0).

Here’s what you will learn from influential women leaders within the life sciences industry about all these shifts:
• Changes in business processes as a result of Covid-19
• Tools that support new business processes
• How to adapt to the cascading swift changes in Quality/IT operations and applications

SPEAKERS

Denise Dajles

Sr. VP of R&D, Regulatory, and Quality, Sientra

Denise Dajles is a Biomedical Engineer with a Bachelor’s and a Master’s degree from Washington University in St. Louis, and is currently pursuing a Doctorate in Engineering Management from George Washington University.

Ms. Dajles has over 15 years of experience, both in industry and academia, leading new product development, global regulatory affairs, and quality management in medical devices. After working for companies such as Inamed, Allergan, and Prosein, Ms. Dajles transitioned to Academia, where she led a Research Lab focused on brain computer interfaces, being the first women to lead a Research Lab in the Electrical Engineering department, and was in charge of over 10 different research projects. Ms. Dajles returned to corporate life after more than six years dedicated to research and teaching to lead the R&D department of Establishment Labs, an Aesthetics Medical Device company, successfully developing over eight different products, taking them from concept to market.

Ms. Dajles currently serves as the Sr. VP of R&D, Regulatory, and Quality at Sientra, also an Aesthetics Medical Device Company, and is responsible for developing the innovation strategy, which includes managing the technology roadmap to address current and anticipated customer needs, leading the design, planning and implementation of the company’s global regulatory strategy and quality system, as well as scouting and assessing new technologies and business development opportunities. Ms. Dajles is also a co-author of several publications in peer-reviewed journals and a book chapter, and is a named inventor on a number of medical technologies.

Dori Gonzalez-Acevedo

CEO, ProcellaRX

Dori Gonzalez-Acevedo has 20 years’ experience in the pharmaceutical industry, specializing in regulatory compliance strategy and computer systems validation. Dori’s focus has been on risk-based strategy and compliance since she started consulting at Genilogix, continuing through to her role as Director of Quality Systems for Healthcare and Life Sciences at Avnet. As a fractional VP of Quality Assurance, she leads BioIT Solutions 1PLATFORM4 Software Suite regulatory and compliance oversight. Most recently as the VP of Strategic Solutions at Tx3 Services, Dori expanded Tx3’s VERA solution and services with a focus on increasing technology adoption and advancing client understanding of compliance, automation, testing, and Digital Validation in the nation’s most visible Life Science enterprises.

Catherine Hall

VP of Data and Quality, Endpoint Clinical

Cat Hall is the VP of Data and Quality at Endpoint Clinical. Cat started her career as an academic scientist in Molecular and Cellular before finishing her MBA and transitioning into Pharmaceutical Supply Chain Management. During her career,she developed notable expertise not only in clinical supplies but also in training development, process improvement, managing partnerships, and the design and implementation of technologies such as IRT. Cat is most well known for her focus on bridging the GMP/GCP gap by bringing supply chain customer service through the last mile to patients. Cat joined endpoint in 2019 and works not only to bring the customer voice into shaping the future of IRT but ensures that our customers are confident that Quality comes first at endpoint.

Elena is a graduate of University of the Sciences in Philadelphia with a BSc in Microbiology and from Temple University with MSc in Quality Assurance/Regulatory Affairs and holds multiple certifications from ASQ.

Originally from New York, she has spent the past 25 years in Pennsylvania with her family and many animals. She has a distinct love of tortoises, most notably her Sulcatas, Jumbo and Franklin.

Elena Mack

VP, Global Manufacturing Quality, Olympus Corporation

Elena is currently VP, Global Manufacturing Quality at Olympus Corporation. Prior to joining Olympus, Elena has prior experience from global medical technology companies such as Becton Dickinson where she served as a Vice President of Quality in support of the global $1.8 Billion revenue business for Specimen Management and prior to that serving as a Vice President, Quality for West Pharmaceutical Services overseeing device manufacturing and contract manufacturing services. Elena has held roles of increasing responsibility in pharmaceuticals, combination products, biologics and contract manufacturing over a span of a continuing 25-year career. Her start in regulated industry was at Wyeth, with a position in Environmental Monitoring in the aseptic environment. That experience sparked a love for all things Quality, focusing on the needs of the patient.

Originally from New York, she has spent the past 25 years in Pennsylvania with her family and many animals. She has a distinct love of tortoises, most notably her Sulcatas, Jumbo and Franklin.

Dinamarie Stefani

Head of Quality, Verily

Dinamarie Stefani is the Head of Quality at Verily (formerly Google Life Sciences) with 25+ years of global experience in pharma and devices. Dina is a lifelong learner and is a recent graduate of the Harvard Business Analytics Program. In her previous role as global Divisional Vice President QA & Compliance at Abbott in the diabetes care division, Dina created an advanced analytics team that generated insights for the upstream (R&D) and downstream (Commercial) teams to enhance the customer experience of the globally distributed continuous glucose monitoring sensor and digital ecosystem.

Dina has held leadership roles at Abbott (Diabetes Care and Medical Optics divisions), Johnson & Johnson (Cardiovascular & Specialty Solutions Group), and Allergan in R&D, Clinical, IT, and QA & Compliance functions while interfacing with the FDA and regulatory bodies around the world. Product experience includes implantables, capital equipment, eye drops, capsules, solutions, injectables, biowearables, apps, and cloud platforms. Product areas encompass eye care, central nervous system, gastroenterology, medical aesthetics, heart rhythm, ENT, sterilization, and diabetes.

Her academic endeavors include an MS in Jurisprudence, Pharma & Medical Devices Law & Compliance from the Seton Hall University School of Law, an MBA from Webster University, and BS in Biomedical & Clinical Engineering from the California State University of Long Beach.

Dina takes pride in working hard and serving others while making time to play hard. She is an avid cyclist, on and off the road as well as on the Peloton. Yoga and Pilates provide her the opportunity to re-center her mind and body. Dina resides in San Francisco with her partner and Golden Retriever, Ella.

Katie Henchir Terry

President and Founder, KT Consulting

Katie is a life science executive bringing over 20 years of experience in drug development, quality, and manufacturing. She holds a bachelor of science in biology from Utica University and a MBA from Simmons School of Management. Katie has held leadership roles at Biogen, Alnylam, and most recently Acceleron, where she was the Vice President of Quality. She has a passion for building global high performing teams, transforming early stage firms nearing commercialization, and promoting a compliance-centric culture. Katie recently transitioned to consulting where she advises life science executives on topics such as quality management systems, manufacturing strategies, and commercial launch readiness.

Ann Vu

SVP, Regulatory Affairs, Quality Assurance and Clinical, ZimVie

Ann oversees quality and regulatory compliance across our global organization. She brings more than 25 years of quality and regulatory experience in the medical device, pharmaceutical, nutritional, and biologics sectors. Ann joined ZimVie from Zimmer Biomet, where she led Quality and Regulatory Affairs for Robotics and several other business units. She has also held progressive leadership roles with global companies, including Ethicon, Ortho Clinical Diagnostics, Bausch + Lomb, and Steris.

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