Meet the Experts Behind Your Success
Our consultants combine decades of industry experience with a shared commitment to innovative, compliance-driven solutions. We partner with you to navigate complex challenges, ensure regulatory success, and drive sustainable growth for your organization.
Phillip A. Minton
Principal Consultant—Quality Systems, NPD/Design, Process Controls & Commercialization
Phillip is a seasoned leader with over 30 years of experience in Quality, Validation, Commercialization, Operational Excellence, and Portfolio Management. He has proven expertise in greenfield and brownfield developments, API manufacturing, and regulated facility expansions, driving initiatives from concept through CQV to commercial readiness. His track record spans start-ups, acquisitions, and Fortune 500 companies, consistently delivering measurable success.
Industry Experience: Healthcare, biotech, medical devices, pharmaceuticals (solid dose, API), life sciences (gene/cell manufacturing), food manufacturing, electronics, and automotive.
Expertise: Skilled in acquisitions, post-merger integration, and equipment/software system rollouts, consistently delivering on milestones while cutting cost and time through value-driven execution. With over 75 transformation initiatives and multi-site remediation actions under his belt, Mr. Minton brings a level of expertise and know-how that minimizes wasted effort on non-value added / limited impact actions.
Lida Ashrafi
Principal Consultant—Food Safety & Quality
Lida Ashrafi is a senior food safety and quality leader with over 15 years of experience supporting food manufacturers across the United States and Canada. Ms. Ashrafi’s business improvement and leadership approach is hands-on, offering strategic advisory services to manufacturers, co-manufacturers, and emerging food businesses working within regulated industries.
Industry Experience:
As a food safety and quality lead, Ms. Ashrafi serves as the primary authority during USDA, FDA, and third-party inspections. Her experience includes stabilizing and scaling enterprise food safety systems and supporting organizations through growth, transition, and remediation.
Expertise:
Her expertise includes regulatory compliance and inspection readiness, HACCP and FSMA-aligned programs, SQF and GFSI implementation and recovery, and sanitation and environmental monitoring systems. She also specializes in root cause analysis, corrective action programs, recall preparedness, and food safety training and leadership development.
Ben Mangawang
Lead Consultant—Business Intelligence, MES, & SCADA Validations
Ben Mangawang is experienced in full project life cycle with progressive levels of responsibility in analyzing business processes, gathering requirements, designing for functional and technical solutions, and implementing application software. A former Oracle consultant experienced with Oracle Customer Relationship Management (CRM) and Oracle E-Business Suite in the Telecommunication, Financial, Healthcare, Insurance, and the Department of Defense industry.
Industry Experience: Managed IT projects for implementing and upgrading e-Content Management Systems, MES and SCADA systems for Bio-Tech/Pharma/Medical Device companies.
Expertise: Skilled in Project Management, Application Implementation Methodology, Six Sigma, Business Requirements Analysis, Business Intelligence, Quality Assurance development, Computer Systems Validation and Security technology.
Alan Leeds
Lead Consultant—Strategic Leadership, CASCADE G&Os & Agile (SCRUM) Execution
Alan Leeds is a strategist, entrepreneur, and motivational speaker dedicated to helping organizations achieve excellence. He holds a Master’s degree from SUNY and a Bachelor of Science from Syracuse University.
Industry Experience: Alan’s core expertise lies in software definition, development and testing for client-specified enterprise systems.
Expertise: Skilled in Client defined needs via holistic software applications.
Heather Kauth brings over 11 years of experience in the pharmaceutical and medical device industries, combining technical expertise with proven leadership in quality and process engineering. She is known for mentoring teams and driving solutions that uphold the highest standards of compliance and innovation.
Industry Experience: Heather has led quality and validation initiatives, managed capital equipment projects, and implemented risk management systems in both pharmaceutical and medical device settings. Her background includes guiding product development efforts and navigating complex regulatory landscapes with a strong focus on operational efficiency.
Expertise: Heather’s core competencies include quality systems, validation strategy, and process engineering. She brings deep technical knowledge in analytical methods, manufacturing processes, and biochemistry—from method validation and IQ/OQ/PQ to formulation development and advanced techniques like freeze drying, chromatography, and bio-reactor operation.
Julius Walker
Lead Consultant- GMP Manufacturing, Commissioning/
Validations
Heather Kauth
Senior Consultant, Quality & Process Engineering
Julius is a seasoned commissioning and validation expert with over 25 years of hands-on experience launching new products, commissioning laboratories and manufacturing facilities, and leading complex CQV (Commissioning, Qualification, and Validation) initiatives. He brings deep expertise in API manufacturing and regulated facility expansions, consistently driving projects from concept through to commercial readiness..
Industry Experience: Healthcare, biotech, medical devices, pharmaceuticals (solid dose, API) and life sciences (gene/cell manufacturing).
Expertise: Key expertise includes manufacturing systems, validation protocols, laboratory testing and execution. As a process expert Julius brings deep technical knowledge in line setup, analytical methods, manufacturing processes and line testing processes.