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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.
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.
Debbie is a senior quality professional with 35 years of work experience in the pharmaceutical and medical device industry. She has extensive experience in technical and managerial positions in laboratory operations, data and documentation management, environmental controls, and quality management systems (QMS) development and maintenance.
She spent 20 years in a high output manufacturing environment with responsibility in multiple disciplines including chemistry and microbiology laboratory testing and operations, data and documentation management, and critical systems. She has extensive experience interacting with a variety of regulatory agencies and multiple types of inspections. This experience enabled her ability to make decisions quickly in a fast-paced environment.
In the past 15 years she has developed a global QMS including creation and revision of policies and procedures, and enhancement of the QMS development, implementation and monitoring processes. More recently, she has been a leader of global laboratory operations, responsible for development and management of strategies, harmonization, continuous improvement, and regulatory compliance.
Debbie’s experience and knowledge has been highly respected. Her leadership and ability to successfully drive projects to successful completions has been recognized globally. She enjoys working with teams of people to improve the health care industry for patients.
Kim is a seasoned executive in Quality with over 30 years of experience across the pharmaceutical, biologic, and medical device industries. Driven by a strong belief in the life-saving and life-sustaining power of medical products, Kim is passionate about ensuring that high-quality, compliant products reach patients. She partners cross-functionally to uphold rigorous standards – always mindful that behind every product is someone’s loved one.
Kim’s career spans 20 years in manufacturing environments and 13 years in divisional and corporate leadership roles. Her hands-on experience includes quality operations, laboratory oversight (microbiology, chemistry, calibration, and physical testing), document management, change control, critical systems, and batch release. At the divisional and corporate level, she has led initiatives in training, CAPA, manufacturing support, supplier quality, technical services, and global Quality Management System development and compliance.
Kim is known for fostering strong cross-functional teams, mentoring future quality leaders, and driving innovative approaches to quality system design. She brings both strategic vision and operational depth to help organizations not only meet compliance expectations but also elevate their quality culture.