Gregg Sherman
AVP, Quality Consulting
Expertise:
Gregg has over 25+ years of overseeing the development and management of quality processes and systems to achieve quality, compliance, and operational goals.
He is a quality and compliance leader with a depth of experience and demonstrated skill defined by a unique perspective on organizational culture and team dynamics, delivering solutions as a consultant, performance improvement professional, change agent, and Project Management Professional (PMP). Leading strategic initiatives, he builds partnerships with all levels of executive and operational/quality management and staff assigned to functional disciplines, including quality, clinical, and manufacturing, including third-party partners such as supply chains, CDMOs, and contract laboratories in the pharmaceutical, biologics, and medical device industries.
Gregg structures and manages projects, defines work tasks and methodologies to focus resources and prioritize effort to achieve objective He also plans and coordinates global Quality Systems design, remediation, improvement, and integration initiatives assisting stakeholders in identifying critical activities and deliverables, best business practices, and eliminating process redundancies for improved quality and compliance posture.
His experiences include directing global teams in developing and implementing quality management systems, metrics and processes for deviation, investigation and CAPA management, change management, document management, training, quality culture management, and batch record certification/manufacturing process development and documentation. He has also led and conducted quality system assessments, mock inspections, and GxP compliance audits identifying risks and deficiencies to implement solutions to reduce compliance exposure and close systemic deficiencies.
Gregg has led a number of multi-year initiatives to include a Quality systems remediation project overseeing 20 consultants at multiple sites, mentoring staff, and initiating process and procedural improvements to numerous systems and workstreams to close regulatory deficiency, managed an 18-month batch record certification program directing 30 consultants on international onsite rotation to review and resolve laboratory and manufacturing batch and deviation discrepancies to certify batches for disposition, and a one-year deviation and investigation improvement project, assessing 800+ retrospective investigations for appropriate categorization, implementing standards, and establishing an investigator qualification program, including training 500+ staff with prospective reviews and mentoring to qualify investigators.
Gregg holds an MS in administration from Central Michigan University and a BS in workforce education, training, and development from Southern Illinois University.
Articles by Gregg Sherman
Inspection Readiness: Building a Continuous Evidence Model
Stop treating regulatory inspections like a fire drill. Discover how to build a continuous, AI-powered evidence model that keeps your quality system permanently audit-ready. When an FDA or regulatory inspection is announced, what happens next in your organization? If the answer involves late nights, chasing overdue tasks, reconciling inconsistent data, and a frantic scramble to assemble a […]
AI in Quality Systems: From Dashboard Reporting to Predictive Compliance Posture
Quality teams are drowning in data. Between deviations, CAPAs, complaints, audits, and supplier metrics, the volume of information is staggering. Yet, many quality leaders are still relying on retrospective dashboards that only explain what went wrong after the risk has already accumulated. Tracking lagging indicators like closed CAPAs and overdue training is important, but it only describes […]
From Quality Metrics to Compliance Signals: What Should Executives Actually Be Measuring?
True quality system maturity requires a fundamental shift: moving from retrospective quality metrics to predictive compliance signals. Instead of just tracking volume, executives must analyze deviation recurrence, CAPA effectiveness, and hidden patterns across their eQMS. By leveraging specialized AI agents to monitor these signals under human oversight, organizations can detect process drift and emerging vulnerabilities long before they […]
Rethinking Quality Systems Compliance in the Age of AI
For pharmaceutical and medical device organizations, the baseline for regulatory trust has fundamentally shifted. Compliance is no longer proved by a shelf of well-written procedures or confident explanations during an inspection. Rather, it is demonstrated by a system’s ability to show that processes are deeply understood, continuously monitored, and actively controlled. Yet, many teams still struggle with simple procedures. While […]
The Stability Advantage: Why Revenue Protection is the New Standard in Commercial Deployment
Is your commercial field force truly operating at full capacity? Even when a team boasts 100% headcount, the reality is that true productivity rarely matches that number. Organizations are quietly forfeiting revenue, not just to market competitors, but to the continuous cycle of vacant territories, extended leaves, and field force disengagement. Are you treating field turnover as an emergency, or managing […]