Jay Wigley, Manager QA/RA
Mr. Wigley has over 20 years of quality assurance and regulatory leadership experience at Fortune 500 and start-up companies. Jay is experienced at designing and implementing quality systems in compliance with 21 CFR 820, 210 and 211 and ISO 13485 regulations and has successfully brought dozens of medical devices to fruition, from design verification and validation to design transfer for manufacturing.
His quality engineering experience bridges a wide product portfolio, from Class I, II, and III medical devices to pharmaceuticals and combination products. Jay’s medical device quality experience includes design and manufacture of electrical-mechanical capital equipment systems and associated diagnostic software, high volume disposable automated manufacturing, and extensive software verification and validation experience across a variety of platforms, from laboratory information systems to automated manufacturing robotics to implantable neural stimulation equipment.
Jay holds a Bachelor of Science Degree from the United States Naval Academy at Annapolis, with further study, including implementation of Total Quality Leadership, at the Naval Postgraduate School in Monterey, California.
Ryan Williams, Senior Project Manager
Mr. Williams is a seasoned project manager with focus on development and manufacturing across multiple industries. From medical devices, OTC and cosmetics to professional services and industrial projects, Ryan has helped a wide range of organizations accomplish their project goals.
During his project management tenure, Ryan has helped major brands develop and commercialize OTC products and has a deep understanding of the OTC business space. Additionally, he has led project teams through development and launch medical device products with national brand leaders, emphasis on wearables and wound therapy products.
He is capable of navigating intense collaboration with large global and diverse cross-functional project teams within matrixed organization from initiation to commercialization with key decision-making responsibility. From managing project scope budget and timeline to navigating complex supply chains, quality management systems and intertwining business priorities he has a proven ability working with business leaders to approve, execute and lead projects to completion.
Ryan has a passion for entrepreneurial thinking and for finding ways to improve processes. That passion, combined with the ability to keep teams dedicated and focused on the task at hand, has helped him successfully launch next generation products, start new facilities, and improve profitability.
Ryan has Certifications in Project Management Professional (PMP) and Lean Six Sigma Yellow Belt (LSSYB).
Lauren Haase, OTC and Rx Regulatory Affairs Manager
Ms. Haase Ms. Haase has over 15 years of experience in pharmaceutical and cosmeceutical commercialization and manufacturing. With high focus on quality and engineering, she has led multifunctional groups through strategic project planning of new and improved quality management systems, utilizing cGMP and ISO auditing, CAPA, root cause analysis, gap analysis, complaint management, supplier management, on-the-job and cGMP training, risk management, and more. She has managed regulatory and quality units of numerous manufacturing sites at the national level, also liaison of multiple contract manufacturing sites at once.
Half of her career has been primarily focused on domestic and international regulatory work, including governing cGMP manufacturing sites, hosting many FDA inspections, responding to 483s and other FDA forms, and being sole contact with the US FDA for previous employers. She has written over a dozen Drug Master Files for topical Rx drugs for the US market and filed 200+ Drug Product Listings for topical OTC drugs according to US monographs. She is also experienced with similar drug filing systems for other international agencies and well-versed with other regulatory affairs needs, such as worldwide Certificates of Free Sale, Certificates of Pharmaceutical Product, etc.
Lauren also specializes in product development processes from stage gate/R&D management and formulation through creation of complete market labeling and full commercialization. She has commercialized many topical OTC drugs currently in the US market, satisfying monograph requirements and drug facts as well as specific needs of the customer or brand.
Lauren holds a Bachelor of Science Degree at the University of Louisiana at Lafayette Mathematics and Chemical Engineering
Daniel Priego, Regulatory Affairs Specialist II
Mr. Priego has over 10 years of hands-on laboratory experience working in pharmaceutical cGMP manufacturing, product testing, R&D, and method development. In addition, Dan has been instrumental in obtaining CE Mark approval for many in vitro diagnostic products under the In Vitro Diagnostics Regulation (IVDR) for the European market. Dan is an experienced data reviewer and has authored many regulatory submissions. He managed multiple laboratory investigations, CAPAs and prepared reports for submission to regulators.
Dan’s capability also includes 510(k) writing and researching peer-reviewed journals and published studies for data to support regulatory submissions. He is up to date with submission procedures for international approvals, and he has significant knowledge of FDA and ICH guidance documents.
Mr. Priego holds a Bachelor of Science in Biology from the University of California, Irvine, and a Master’s Degree in Biotechnology Regulatory Affairs from the University of Maryland
Kristie Williams, Government Affairs Manager
Ms. Williams has more than 20 years of experience in clinical trials with in-depth experience in all areas of research, including research operations, administration, clinical trial management, finance, human resources, and talent management. Her career in clinical research includes evaluation of submissions, awards, and agreements for compliance. She has provided pre-award and post-award guidance and processing of simple to complex research grants and contract applications, awards, and agreements.
She has extensive work experience with Institutional Review Board applications while working closely with the Institutional Review Board to oversee clinical trials. Ms. Williams breath of knowledge also includes an extensive knowledge in the design and implementation of Good Clinical Practices and Compliance in relation to clinical trials.
Ms. Williams holds a Masters Degree in public administration with a concentration in health care administration.
Sandra Gawlowski, Clinical Research Coordinator
Ms. Gawlowski has over 8 years extensive Project Management experience from concept to development to implementation in clinical research. Talents include in-depth knowledge of ICH guidelines, adverse event reporting, GCP auditing and coordination of a variety of clinical research studies.
She is well versed in study protocols, standard operating procedures, and general trial oversight.
Her quality of work is exemplified in the problem-solving ability and detail-oriented nature which is utilized in the effective collaborations with teams for successful production of clinical trials ranging from industry, cooperative, iiT, federal and NIH studies. Sandra specializes in establishing project objectives, developing experimental plans and effectively prioritizing tasks to meet time sensitive delivery goals. She has served effectively as a point person for executing phases I-III research projects and disseminating findings to leadership.
Sandra holds a Bachelor of Science from Arizona State University in Molecular biosciences and biotechnology and has extensively grown her career and passion for clinical research into a variety of successfully implemented and completed studies.
Brooke Hamby, Social Media & HR Manager
Ms. Hamby has many years of experience with non-profit organizations, academic institutions, and the small business sector. Her expertise lies in using her extensive knowledge of multimedia technologies for a wide variety of purposes. She has extensive experience with marketing strategy, content creation, brand development, online publishing, social media management, and collaboration integration tools. Brooke has related experience in budget and grant preparation, hiring logistics, bookkeeping, marketing, and managing and training staff. During fifteen years working in non-profit education, she developed an expertise in adult professional development, qualitative data analysis, research, and coaching.
Brooke holds two master’s degrees, a PhD, and an EdS in Educational Leadership.
Jennifer Jones, Office Manager
Ms. Jones has over 20 years of business and office management experience. Her expertise lies in accounting and bookkeeping. She has extensive experience with QuickBooks software. Jenn excels at organization and is extremely detail oriented. She is also experienced at employee and inventory management. Jenn has spent the last twelve years in the role of office manager for a small business where she was responsible for the management of all everyday activities and employees.
Jenn holds an Associate Degree of Business Management from Kent State University