GMP Life Science

Bob Miseyka

Owner and President, Life Sciences Division

Bob Miseyka is President and a Managing Partner of Raland Compliance Partners, and directs the Life Sciences Compliance Division for the company.

Prior to merging with Raland in 2014, Bob was Managing Partner of Compliance Partners, LLC for twelve years. As a founder of Compliance Partners, Bob successfully built the company on a national and international basis. Bob has a 35 year history in Life Sciences support services, in particular for FDA regulated, technical and scientific disciplines. He previously owned an engineering technical services company as well as a financial services firm.

Bob is a graduate of the Edinboro University with a BA in Mathematics and additional post-graduate work at Gannon and Purdue Universities in Business and Industrial Management.


Bob Lawrence

Vice President and Executive Director, Life Sciences

Mr. Lawrence is a 26 year industry expert and the Vice President of Life Science Division. He is a Senior Quality Professional with proven record in Project Management, FDA Audit Support, Investigations and CAPA implementation, Quality Systems Development, CD Remediation Projects, QA Management, GMP Consulting, Master Validation Planning, Protocol Development and Execution (IQ, OQ & PQ), Commissioning & Qualification of New and Retrofit facilities, Audit / Inspection, PM & Calibration System Development / Design, Technology Transfer, Sterilization/Depyrogenation, Computer Systems (Part 11), Instrumentation & Controls, Critical Utilities / Water Systems, Sterile Process Equipment, Sterile Filling and Packaging Equipment and Process Validation.

Bob has expert Industry Experience; Medical Device, Aseptic, Biopharmaceutical, Solid Dose, API, Nutraceutical, Clinical, Blood Fractionation, R&D, and Animal Health as well as Laboratory environments. He holds a degree in Life Sciences and is a member of ISPE, PDA, RSES and ASE.


Amber Quitno

Vice President, Talent Acquisitions

Amber Quitno is Vice President, Talent Acquisitions, for the Life Science Division of Raland Compliance Partners. Prior to joining Raland Compliance Partners, she was President and founder of EltiePharma Staffing & Placement.

Amber has over 12 years of experience in the Life Science Industry combined with her experience in Human Resources. She began her career in the industry as a Regulatory Writer, but soon realized she could best serve the industry and her career goals by combining her Human Resources and hands-on experience in the Life Science Industry.

The relationship with Raland Compliance Partners and ElitePharma Staffing flourished over the years working together, and the decision to join forces became the obvious next steps for them to provide their clients with the best sourcing power possible.

Amber has a master’s degree in Regulatory Affairs in Drugs, Biologics, and Medical Devices and a Certificate in Human Resource Management and Services.


Tom Rynkiewicz

Vice President of RA/QA

Tom is the Vice President of RA/QA and responsible for leading our Regulatory and Quality solutions delivery, client relationships, and market positioning. Tom has over 30 years of industry experience including 14 years internal to the pharmaceutical industry and nearly 20 years as a strategic consultant supporting operations and compliance projects for life science manufacturers, both domestically and abroad. Because of his extensive life science industry experience, Tom is regarded by clients as a trusted partner who can quickly understand their needs and leverage the experience, knowledge, and resources of the Raland team to have an immediate impact on RA/QA projects or strategic initiatives.

Tom is an ASQ Certified Quality Auditor and hold a Bachelor of Science degree in Business Management.

Clinical

Patricia Rader

Vice President, Clinical and Communications

Patricia Rader leads both our Clinical and Communications Divisions. Patricia Rader has over 25 years' experience managing and delivering strategic programs in commercial and regulated environments, including the BioPharmaceutical industry, the US Government, and the Department of Defense (DOD).

Patricia's experience in US Government and DOD projects included management of integrated teams to deliver product and support to tactical programs of varying clearance levels, according to Mil-spec standards for logistics and delivery.

In the commercial arena, Patricia led integrated, strategic teams to create blended presales and technical training programs to support new product launch, world-wide in the cell phone industry and in the production print industry. In these roles, Ms. Rader developed strategies to support a wide variety of population needs, and implemented solutions based on the principles of Lean Six Sigma and Time-to-Market.

Patricia joined Raland in 2006, creating the Learning Solutions Division with the goal of providing results-driven training to the BioPharmaceutical industry. Her role in this area included partnering with clients to develop comprehensive training strategies based on client goals, and creation and implementation of training and documentation projects to support adherence to CFR and international regulations. As lead consultant, Patricia designed and fielded a strategic, blended training program to support process operations of a new biologics facility. In this role, Patricia was instrumental to the client's win of the Facility of the Year Award, 2011.

Her most recent role in Raland Compliance Partners was as Chief Operations Officer; managing all areas of company operations, including all internal support and financial systems, Human Resources, vendor services, and client support.

Ms. Rader has a BS in Communications from the State University of New York, Brockport, and certificates in Instructional Design from Rochester Institute of Technology.


Dorcie McKniff Jasperse, Ph.D.

Executive Director, Life Sciences

Dr. Dorcie McKniff Jasperse has more than 30 years of experience in clinical trials and medical research. She has worked in the government, academic, and commercial settings as a data manager, statistician and epidemiologist, project and program manager, GCP auditor, and manager of GMP auditors.

In her research roles, Dr. Jasperse has performed or managed testing of therapeutic modalities with new drugs and new devices and explored various epidemiologic hypotheses. In addition, her personal research has ranged from testing various data management methodologies to exploring different physiological mechanisms under controlled environmental conditions. She earned her master's degree in biostatistics and epidemiology from Georgetown University, and her Ph.D. in exercise physiology and cardiac rehabilitation from the University of Pittsburgh.

Dr. Jasperse worked as a statistician and epidemiologist at the University of Pittsburgh on a longitudinal maternal health project, exploring the effects of drug, alcohol and cigarette use by expectant mothers on the neonate and beyond. While there, she also performed research at the university's Human Energy Research Laboratory.

After receiving her doctorate, she returned to regulated clinical research and provided project management and statistical services such as 510(k), PMA, IND and NDA to various industry clients.

Training and Communications

Michael Antalek

Director, Communications and Information Technologies

Michael Antalek has more than 25 years of experience in instructional design and development of computer-delivered, video, and instructor-led training applications. This unique blend of multimedia development and instructional design contributes to the quality of multimedia and training solutions delivered by Raland Compliance Partners.

Mr. Antalek has served as the lead designer, developer, and project manager for many computer-based training applications and performance support tools for Xerox Corporation, Eastman Kodak Company, Ford Motor Credit, Goulds Pumps, Getinge USA, and Pratt & Whitney.

In addition to training delivery, Mr. Antalek also led the design and development of a sophisticated, proprietary learning management system (LMS) that employs a unified code base for operation on the web, local area networks, and standalone personal computers.

Prior to joining Raland Compliance Partners, Mr. Antalek served as the Director of Engineering for EspriTEC; as the Manager of Instructional Design for Global Learning Technologies, as a Senior Technical Instructor for Landis & Gyr Powers, and as a Master Training Specialist at the United States Naval Nuclear Power School.

Mr. Antalek holds an M.S. degree in Engineering Management from the University of Central Florida and a B.S. in Aerospace Engineering from the State University of New York at Buffalo.

Language Services

Olga Gulkewycz

Vice President, Translation & Language Services

Ms. Gulkewycz is the Vice President for the Translation and Language Services Division of Raland Compliance Partners. Prior to managing the Translation department, she held various positions throughout her tenure at Premier Technical Services including Instructional Designer/Trainer, Technical Writer and Project Manager, Sales and Marketing Manager and General Manager.

Olga has over twenty years of training experience, and ten years of translation solutions and services experience. Prior to joining Premier Technical Services, she worked at Xerox Corporation acting as a Training Program Launch Manager for the North American Solutions Group supporting Office/Production Color and Mid-volume Black & White Product Lines.

Olga has completed full coursework for her BS in Organizational Management from Roberts Wesleyan College, as well as obtained certificates in Curriculum Design and Development using the Criterion Referenced Instruction method of writing, and International Business (through the Rochester International Business Council/RBA, NY). She has also held membership affiliations with the American Society for Training and Development (Board of Director Member/VP of Marketing) - Genesee Valley ASTD 2006-2008); Association for Women in Computing, and Rochester Women's Network.


Dr. Wei Xin Vought, Ed. D.

Director of Operations, Language Services

Dr. Wei X. Vought has more than 20 years of experiences in business and project management in both Asia and America. She has in-depth knowledge of the translation and interpretation industry, and specializes in ISO audition, Kaizen implementation, and corporation training. Prior to joining Raland in 2018, Dr. Vought worked as a project or technology manager at Conduent, Xerox, and Raland Technologies. Dr. Vought also has experiences in small startup businesses and not-for-profit organizations.

Dr. Vought attended Huazhong University of Science and Technology and received her Bachelor of Arts degree in 1993. She earned her Master's in Business and Administration and Doctorate in Education from Saint John Fisher College, Rochester, New York. Her dissertation topic is on virtual leadership in multinational corporations. She graduated with high honors and is also a lifetime member of Beta, Gamma, and Sigma Society; and, she has served on the boards of Chinese Institute of Rochester and International School of Music and Art of Rochester since 2013.