Speakers
Dana Jones
Chief Executive Officer, Sparta Systems, Inc.
Dana Jones is Chief Executive Officer and a member of the board of directors for Sparta Systems. In this role, she leads the organization and has responsibility for all aspects of the company.
Jones is an accomplished software executive with decades of experience leading and growing cloud-based global businesses. Prior to joining Sparta in April 2018, Dana served as CEO of Active Network, the leader in activity and event management software. Under her leadership, the company grew rapidly, leading to the sale of the Sports and Communities divisions to Global Payments Inc. (NYSE:GPN) for $1.2 Billion.
Before joining Active Network, Dana was Chief Marketing Officer and Senior Vice President of Solutions Management for Sabre Airline Solutions, a global provider of software to the airline industry. During her time at Sabre, Dana drove double-digit revenue and earnings growth and accelerated product innovation. She transformed the organization into a market-driven software company and played an important role in the company’s successful IPO. Prior to Sabre, Dana co-founded Noesis Energy, and served as its EVP of Product, Sales, Marketing, and Operations. Dana has held Executive and General Management positions for early stage and global publicly traded enterprise software companies over the last 20 years, including The Reynolds and Reynolds Company and Vignette. She started her career as a management consultant with A.T. Kearney focusing on strategy and supply chain optimization initiatives for Fortune 500 companies.
She graduated Summa Cum Laude and holds a BSE in industrial and operations engineering from the University of Michigan.
Stephen McCarthy
VP, Digital Innovation, Sparta Systems, Inc.
Stephen McCarthy is Vice President of Digital Innovation at Sparta Systems. Steve is uniquely qualified to enhance Sparta's mission of advancing the value of Quality Management Systems for our customers. He has a key responsibility to aid our customers successfully transition to digital technology when they are ready. Steve serves as a key resource across the company, sharing his leadership, innovation and experience while contributing to customer interactions, marketing activities, industry leadership events and product development. In this role Steve supports Sparta’s mission of helping the industries we serve to improve product quality and safety, streamline their operations, and lower risk and ensure compliance, using innovative cloud solutions that support an all-digital strategy.
Kareem Elwakil
Director, Pharmaceuticals and Life Sciences Consulting, PwC
Kareem is a New York-based leader in PwC's pharmaceutical and life sciences management consulting practice, where he specializes in transformation across the medical device value chain. He has advised clients on a range of topics, including operations, quality strategy and systems, M&A diligence, integration, carve-out, and value capture, and regulatory affairs and compliance.
Kareem also leads an exclusive medical device quality roundtable and has overseen multiple organizational and performance-related benchmarking studies around quality, compliance, and regulatory affairs. He is a frequent speaker at medical device industry conferences and forums and has supported key industry initiatives as a leading subject matter expert, such as AdvaMed’s “Case for Quality” Quality Culture work.
Jan Paul Zonnenberg
Principal Pharmaceuticals and Life Sciences Advisory, PwC
Jan Paul (JP) is a partner in PWC’s Life Sciences Practice and co-leads PWC’s Quality Practice. He specializes in Quality Transformations for Pharmaceutical, Biotech, and Medical Device companies. He has successfully led several companies in managing Consent Decrees, Corporate Warning Letter, and 483 remediations. However, his real passion is driving cultural transformations throughout the industry. His experience includes major GxP-wide transformations from a Cultural Process and Digital perspective. Jan Paul has also developed the industry leading Quality 4.0 framework. He has published and presented at several major venues and leads various Chief Quality Officer roundtables.
Education and certifications
Jan Paul received his Master of Business Administration from Boston College with concentrations in corporate finance and strategic management. He is a graduate of the University of Georgia, where he obtained a Bachelor of Business Administration with a dual concentration in corporate finance and management information systems.
Jan Paul has over 30 years experience in pharmaceuticals, biotechnology, medical devices, and diagnostics.
Cynthia Schnedar
Executive VP, Regulatory Compliance, Greenleaf Health
With more than 30 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government – Cynthia adds to Greenleaf Health’s prestige as Executive Vice President, Regulatory Compliance.
Cynthia was formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER), where she led a staff of more than 300 doctors, scientists, manufacturing experts, pharmacologists, attorneys, and administrative staff. During her time at FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA Commissioner, the CDER Director, and other senior FDA officials on significant enforcement issues.
Before joining FDA in 2014, Cynthia spent more than two decades at the Department of Justice (DOJ), where she specialized in compliance and enforcement issues. Her most recent position at DOJ was as Deputy Inspector General and Acting Inspector General, where she led a nationwide staff in investigating allegations of corruption and misconduct concerning DOJ’s employees and in conducting independent performance and compliance audits of the Department’s operations and programs. She communicated significant findings from the investigations and reviews to the Attorney General and to Congress.
Cynthia’s other positions at DOJ also provided her with an extensive background in criminal and civil enforcement work. They included Counselor to the Inspector General, Deputy Chief of the Sex Offense and Domestic Violence Section in the U. S. Attorney’s Office for the District of Columbia, Assistant U. S. Attorney, and Trial Attorney in the Civil Fraud Section of the Civil Division.
Previously, Cynthia clerked for a federal judge on the Ninth Circuit and worked as a television reporter in New Mexico and Texas.
Cynthia earned a B.A., with distinction, from the University of New Mexico and a J.D., with honors, from the University of Texas School of Law.
Hari Subramanian
VP, Product Management, Sparta Systems, Inc.
Hari Subramanian is the Vice President of Product Management at Sparta Systems. Hari is responsible for evolving our product management practices and driving the product strategy and roadmap. Hari has helped to shape product strategy, implement product management best practices including 18-month roadmap, and revise product pricing.
Prior to Sparta, he served as a product leader responsible for driving the vision, strategy, roadmap, pricing and overall profitability of a $500M enterprise product suite.
Barry Cook
VP, Global Quality Operations, McKesson Corporation
Barry is an influential pharma and medical device quality executive with over 25 years of deep domain expertise in FDA, international regulations and standards, product and process development, global requirements for new product introductions, clinical research, and product life cycle management. Barry is the VP of Global Quality Operations at McKesson, and holds a degree in Chemistry and Biology from Central Methodist University.
Gary Chambers
Global Head, Life Sciences, SGS Group Management Ltd
Gary Chambers, Global Head for Life Sciences at SGS since 2018, leads the business development strategy and growth plan for the integrated network of analytical testing laboratories across North America, Europe and Asia-Pacific.
He joined SGS in 2014 as business manager for the biologics characterization and R&D sites across Europe, then in 2016 was appointed as Global Head of Regulatory and Compliance for the life science segment, part of the 1 B+ CHF Agriculture, Food and Life division at SGS.
Gary started his career in life sciences working on the ground-breaking cloning project “Dolly the Sheep”. Since then, he has held senior executive positions in a number of international biopharmaceutical, CRO and MedTech companies, delivering high growth in multi-channel, global markets. With a proven track record in repositioning organizations and financial planning, Gary’s customer-centric approach produces quick and sustainable results within complex working environments. His passion and drive to make a difference through strong communications and relationship building enables him to lead performant teams to achieve critical strategic goals.
Commercially focused, Gary specializes in impact-driven financial models, business transformation, and operational management delivering year-on-year growth by managing streamlined teams that operate with agility in culturally diverse regions.
With a solid background in veterinary medicine and supply chain traceability working on the family’s farming business, which includes a wind farm producing green energy, Gary brings to SGS’ Agriculture, Food and Life division a deep knowledge of business transformation, organizational and change processes, as well as dynamism and direction to see projects to conclusion.
Badri Devuni
Life Sciences Director, Salesforce
Badri is an experienced Life Sciences leader in the Salesforce Industries team and currently leads the Go-To-Market strategy for Life Science at Salesforce. Over the last 16 years, he has helped Life Sciences companies re-imagine their commercial & research processes and drive digital transformation. He has extensive experience building vertical solutions informed by industry trends, scaling and augmenting capabilities through partnerships and bringing the solution to market.