Crystal Mersh is the founder, president, and CEO of QxP. She holds a bachelor’s degree in chemistry from Fairmont State University and has spent 25 years in the pharma industry in senior level positions with companies such as Novartis, Mylan, Sanofi, and Allergan. Her experience at these companies led her to create a revolutionary approach to consulting, delivering long-term transformational change in the pharma industry with the founding of QxP in 2012.  Crystal also has extensive experience in remediation, consent decree management, warning letter resolution, and continuous improvement for quality systems, workflows, and operations. She has led QxP in numerous, global engagements, specializing in regenerative medicine and immunotherapies, and has committed QxP to influencing regulatory and industry standards in the pharma industry while setting the platinum standard in life sciences education. The development and launch of Virtuosi are a key part of Crystal’s vision for leading-edge pharma education.

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Uriel Kusiatin is the chief financial officer for QxP.  He holds a bachelor of science degree from the Technical University of Denmark as well as an MBA in strategy and finance from the Wharton School. Uriel has more than 20 years of experience in the life sciences industry as a C-level executive and management consultant to both small startups and large pharma organizations. He has advised senior executive teams, multiple board of directors, and investors on business strategy, commercialization, operational execution, and financial management. Over the past 8 years, Uriel has been CFO and CEO for a venture-backed liquid biopsy company focused on breast cancer detection and other women’s cancers.  He led the company through $50 million in capital raises, a sale to a private equity firm, and, most recently, the sale to a publicly traded molecular diagnostics company.

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Brian Duncan is the chief operating officer for QxP, providing operating oversight for all global consulting engagements. Brian graduated from the U.S. Air Force Academy and then completed his bachelor’s degree in chemistry at the University of Texas at San Antonio. Since 2014, he has held various executive leadership positions, including senior vice president of global sales and deployment for Virtuosi. He is a seasoned leader, having held numerous senior and executive positions within the pharma industry. Brian has also worked with dozens of global pharma companies developing, deploying, and managing various strategic programs. These programs focus on remediation, mergers and acquisitions, site expansions, global standards alignment, education, and local capability enhancements. In addition, he has developed and led the daily execution of six successful warning letter and consent decree programs. All programs resulted in full resolution within record time (typically 12 months or less) with results that were sustained for several years at the local, regional, and global levels.

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Nicole Monachino is the chief legal officer and Head of business operations for QxP. She graduated from Hiram College with a bachelor’s degree in management and received her juris doctorate at the University of Notre Dame Law School. Nicole is a results-oriented business executive and attorney and a trusted advisor to cross-functional teams that drive strategic corporate initiatives. Combining this diverse experience, Nicole excels in identifying creative solutions to complex problems in all aspects of GxP remediation, pharmaceutical development, manufacturing, sales, and marketing. She navigates the complex legal and business framework of the pharma industry for QxP and is recognized for building strong relationships with senior business leaders, during times of ambiguity and crisis.

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Robin Mersh is the senior vice president of Sales for QxP. He graduated from Queen Mary University of London with a bachelor’s degree in history and politics and is an accomplished senior sales executive with over 20 years of success selling advanced technologies, including virtual reality, broadband, cloud, data centers and e-business. His sales focus is on the flagship product, Virtuosi — virtual reality education for the pharma industry in manufacturing operations and biotech.  Robin is an expert in strategic leadership, management, sales, channel and partner management, and cultivating client relationships. He is also able to identify opportunities for facilitating growth within an organization and securing positive results.

Mike Levitt is the vice president of strategic operations for QxP. He graduated from the University at Buffalo and is a veteran operations senior executive with more than 40 years in the pharma industry working at Eli Lilly, Solvay, and entrepreneurial biotech companies. At QxP, Mike leads project teams, supporting clients with new product approvals, quality systems remediation, and operational improvements.  In addition, he specializes in regulatory inspection preparedness education and assists clients in responding to enforcement actions. Mike has devoted his career to bringing innovative health care products to patients around the world.

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Becky Brewer is the strategic practice lead at QxP. A graduate of Mount Hoilyoke College specializing in biology and chemistry, Becky has more than 25 years of direct pharma experience in the areas of quality, compliance, and continuous process improvement. She has held numerous positions within the pharma industry, specializing in cleaning validation and engineering, process validation, production controls, and manufacturing. Additionally, Becky has significant experience with risk assessment, control strategies, continued process verification, and manufacturing facility design. She teaches for ISPE, PDA, and the University of Wisconsin, as well as other conference organizations.

Robert (Bob) Ferer is the vice president of consulting operations at QxP. A graduate of the State University of New York at Stony Brook, Bob is an engineering chemist and has more than 29 years of direct pharma experience with the design, build, startup, and management of facilities, specializing in aseptic manufacturing. His operational experience covers all aspects of pharma operations, from receipt of raw materials through inspection, final packaging, and shipping of finished products. In addition to operations expertise, Bob has been instrumental in multiple projects related to new facility design and startup. This includes developing and executing project master plans, schedules, and budgets, performing hands-on validation, design review, and equipment startup, and commissioning. He provides high-level consultation to clients on regulatory and compliance issues related to operations, engineering, and facility design for US and EU markets.

Kathy Meyer is the vice president of program management for QxP. She graduated from the University of Colorado Boulder with a degree in molecular, cellular, and development biology and completed her master’s in business with an emphasis in technology management. Kathy joined the pharmaceutical industry in 1993 and has held several executive leadership roles in the fields of quality, compliance, manufacturing, supply chain, program management, and business development. In addition, she has supported and managed regulatory inspections and remediation programs and also successfully implemented multimillion-dollar projects and launch preparation strategies to improve time to delivery for patients. At QxP, Kathy serves as editor and program manager for Virtuosi. She has been recognized as a "Rising Star" by the Healthcare Business Women’s Association.

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Vanessa Figueroa, Pharmaceutical Microbiologist and Consulting Partner, has more than 13 years combined experience in Pharmaceutical, Biotechnology and Medical Device industries. Vanessa has expertise in sterility assurance, environmental and utilities monitoring programs and quality control laboratory management. Her consulting experiences have spanned both domestic and international large pharmaceutical companies, applying both US and global regulatory standards of quality. Her current role as Executive Director of Microbiology for QxP is focused on the development of Virtuosi, an innovative and revolutionary education and training product for the pharmaceutical industry. Vanessa has a Bachelor’s degree in Molecular Biology from State University of New York at New Paltz and a Master’s degree in Molecular Biology and Microbiology from San Jose State University. She is an active and publishing member of several professional organizations, such as the Parenteral Drug Association, American Society of Microbiology and Association for Women in Science.

Mark Roache is a consulting team lead for QxP. He graduated from the University of Leicester with a Master of Science degree in biomolecular technology and has been in the pharma industry for more than 10 years addressing quality and regulatory issues. Mark specializes in organizational change management, facility startup, and commercialization and quality systems design.

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