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“Proven Experience”
Greg is the Founder and President of APEX Performance Excellence Group and has over 30 years of experience in the Medical Device Pharmaceutical Industry. Greg began his professional career working in an aseptic filling manufacturing operation. The various roles that Greg held during a that period afforded him an unbelievable opportunity to grow and develop what has evolved into a life long passion – getting work done effectively and efficiently through the engagement of people.
Understanding that any organization’s success starts with leadership, Greg pursued a corporate support role for two years that focused on leadership development and the values and behaviors required for success.
With a desire to get back to where the work gets done, Greg joined a corporate Business Excellence Group that was responsible for supporting internal business units, regions, functions, and groups in their pursuit of excellence. The group provided advanced skills in process/system design, lean, six sigma, green/black belt deployments, and Baldrige based assessments. This opportunity was the job of a lifetime. Greg spent over eight years with the group harnessing his skills around leading large-scale process/system design and continuous improvement efforts. Greg was given the opportunity to work with every level and every function within the corporation. From R&D, manufacturing, service, quality, sales, marketing, engineering, human resources, and yes-even legal, he was able to assist in improving almost every known process within an organization.
Starting in April of 2011, Greg continued his journey by founding APEX Performance Excellence Group. In his role as President, he has managed a professional management consulting firm that specializes in process/system design, operationalization of requirements (FDA, ISO, Baldrige, Strategic Plans, etc.) and continuous improvement (Lean, Six Sigma, DMAIC, etc.). In his roles in supporting clients he has designed, developed, and implemented comprehensive, enterprise-wide process business solutions for business units, regions, functions, and groups.
Chris has 30 years of experience in the Medical Device/Pharmaceutical industry, including military service. After completing tours as a Surface Warfare Officer in the U.S. Navy, Chris began a new professional career in medical device R&D and Sustaining Engineering. This provided a fantastic opportunity to continue a passion for service – to patients and their families.
Chris developed a drive to achieve standards of engineering excellence, coupled with a strong awareness for practical application. To that end, he honed skills of lean enterprise and six sigma methods, developing a passion for finding root causes of problems and finding cost-effective and balanced solutions. As a quality engineer in Design Assurance/ R&D, he owned all QA aspects of design controls for a new anti-microbial needleless IV connector. This afforded an opportunity to manage the full QA lifecycle of a device, from pre-market inception through post-market surveillance and sustaining engineering projects.
Seeking new challenges, Chris pursued a corporate Six Sigma Black Belt certification and joined the Business Excellence group. He relished an opportunity to partner with various internal functions to develop process-focused system design including analytics, value stream mapping, control-charting, and capability studies.
In 2011 he co-founded APEX Performance Excellence Group, continuing an ongoing personal journey of bringing high-quality solutions to ambiguous and complex problems. During this period, Chris led numerous Class II and III medical device quality system process development efforts, including the development of an FDA/ISO 13485 compliant Quality Manual. He also managed technical aspects of a Warning Letter-driven remediation effort and led a team of engineers in remediating manufacturing controls on a multi million-dollar product line.
What drives his passion today is the knowledge that workforce engagement, leadership, and disciplined process execution are keys to the success of any organization.
Wendi has been a pharmaceutical quality professional for over 30 years. She started as a chemist in an aseptic-fill solutions plant where the fast-paced, high pressure manufacturing environment provided her with growth opportunities to excel in many areas of pharmaceutical operations, including formulation, laboratories, quality, and supplier management. Increasing responsibilities in managerial roles developed her skill and confidence in making important operational decisions quickly and effectively.
After 14 years in manufacturing Wendi moved into an R&D Quality role and later into Stability Operations. She held responsibility for four departments (Documentation, Environmental Storage, Stability Reporting, and Chemical Storage) including maintaining inspection readiness and involvement with numerous supplier audits and FDA inspections.
In the past 10 years, Wendi has consulted for many pharma and medical device companies, primarily in quality assurance, stability, and supplier management roles. Her ability to quickly adapt to new systems, processes, and procedures has afforded her much success in maximizing output in short-term projects.
Wendi’s passion for sharing knowledge and experience with clients, coupled with a sincere desire in helping others be successful has brought her much satisfaction.
Pearline is a 30 year plus senior quality professional with a proven track record specializing in technical and managerial roles within pharmaceutical, medical device, biotechnology, consumer products, nutraceutical, and food industries. She has extensive experience establishing global quality management systems, SME for inspection readiness, FDA mock audits, CAPA management, supplier quality management, post market surveillance and adverse event/MDR/MDV reporting. She has focused expertise in manufacturing quality, clinical quality assurance, FDA/ISO audit management and compliance to include internal, external, clinical, mock, CMO and supplier audits.
Pearline is a certified Exemplar Global Master Auditor, and her passion lies in quality auditing and helping companies to become and remain audit ready at all times. She has over ten years’ experience working in various compliance roles with Johnson & Johnson Family of companies, in addition to stints with Baxter Healthcare, Boston Scientific, Philips Healthcare, NAMSA, and Kimberly Clark Healthcare.
Elsio is an Operations Management practitioner with over 30 years of experience in Medical Devices, Food and Consumer industries. He has held a variety of increasing leadership positions in Fortune 100 companies within the Manufacturing, Transportation & Warehousing, and Professional, Scientific and Technical Services industries in both, process-intensive and labor-intensive environments.
Completing his college degrees while working full time in a manufacturing company, Elsio developed a resolute desire to study and practice Business Administration and Operations Management. His business acumen and ability to engage at the process level enabled him to lead multidisciplinary teams in the resolution of complex issues.
After over three decades of contributing, managing and leading various functions, Quality, Manufacturing, Materials Management, Business Excellence and Supply Chain, he founded his own consulting firm focused on helping companies reach their full potential. With his vast experience as a practitioner and a recognized leader in Operations Management, Elsio has assisted many companies in the implementation of integrated business management processes, supply chain management, and manufacturing excellence initiatives driving improved business performance and sustained results. His achievements led him to be recognized as Manufacturing Manager of the year by the Puerto Rico Manufacturers Association (PRMA) and the Southwestern Industrial Association (SWIA).
Elsio earned a BBA in Purchasing and Materials Management from the American University of Puerto Rico and an MBA in Industrial (Operations) Management from the Interamerican University of Puerto Rico.
Elsio sees his role as a rewarding and fulfilling vocation assisting organizations in their transformational journey via a fusion of a scientific core with the knowledge, experience, resolve, and delivery of their human element.
Hector is a 30 year-plus experienced senior quality professional with extensive background in small and large volume sterile injectables and medical devices. He has cultivated significant strength and experience in addressing complex issues and working with multidisciplinary teams. Hector’s track record demonstrates passion for developing quality systems within pharmaceutical, medical device, and biotechnology companies that add value and efficiency in addition to being compliant with regulations. Additionally, he has extensive experience interacting with the Food and Drug Administration and other global regulatory bodies.
Hector’s work experience includes over 24 years contributing, managing, and leading in various roles as a member of quality organizations with major pharmaceutical and medical device companies. He also has 15 years of experience working as an independent consultant within this industry in the USA, Europe, India and the Americas.
Hector holds a degree in Biology with master’s degrees in Biochemistry and Molecular Biology. He particularly enjoys being a mentor and guide for those wishing to improve patient lives through the work they do.