Zürich Metropolitan Area
Certified: ISO 13485:2016 Lead Auditor Medical Devices (Exemplar Global MD) Auditing Management Systems (Exemplar Global AU) Leading Audit Teams (Exemplar Global TL) GMP Strategist | Stabilizing Global Quality Systems for Sustainable Compliance | Independent Audits & Data Integrity With 30 years of experience in the regulated life sciences industry, I have observed a recurring pattern: organizations often focus on theoretical compliance, while the actual "Architecture of Compliance"—the way decisions are made and documented on the shop floor—remains fragile. My Approach: The Inspection-Oriented Perspective I do not view Quality Management Systems (QMS) as a collection of SOPs, but as a strategic asset. My With more than 30 years of experience in regulated life sciences environments, I support pharmaceutical manufacturers during critical GMP compliance, supplier qualification, and inspection-readiness activities. My work focuses on: • GMP Supplier Qualification Audits • EU GMP / FDA Inspection Readiness • Mock Audits & Gap Assessments • Quality System Stabilization • Interim GMP Compliance Support • Data Integrity & ALCOA+ Risk Assessment Available for international projects across: • Europe • India • API Manufacturers • CDMOs • Drug Product Manufacturing • Sterile & Non-Sterile Operations I work from an inspection-oriented perspective. I do not assess Quality Management Systems as collections of SOPs or isolated compliance documents. I assess how systems behave under operational pressure: • how deviations are escalated • how decisions are made • how ownership is exercised • how CAPAs are managed • how data integrity risks emerge in daily operations • how effectively Quality Oversight functions across departments My audits and assessments are designed to identify these structural weaknesses before they surface during regulatory inspections. Core Areas of Expertise: • GMP Supplier Audits & Qualification Programs • EU GMP / FDA Inspection Readiness • GMP Gap Analyses & Mock Inspections • CAPA / Deviation System Evaluation • Data Integrity & ALCOA+ Assessments • Site Master File (SMF) & QMS Structures • Quality System Stabilization under operational pressure • Independent GMP Audits for pharmaceutical manufacturers • Audit preparation for international regulatory expectations Certified: • ISO 13485:2016 Lead Auditor Medical Devices (Exemplar Global MD) • Auditing Management Systems (Exemplar Global AU) • Leading Audit Teams (Exemplar Global TL) “GMP does not fail on paper. It fails — or succeeds — in daily practice.”
I am the Founder and Principal Consultant of Schmidt GMP-Consulting, supporting pharmaceutical manufacturers with EU GMP, USP, and international GMP inspection readiness. My work focuses on how quality systems are perceived by regulators and inspectors in practice, not how they look on paper. I support companies before, during, and after audits and inspections through objective gap analyses, mock audits, and inspection-oriented decision support. My approach is audit-driven and experience-based, not checklist-driven. I work closely with QA, QP, and management teams to identify critical compliance risks, prioritize actions, and stabilize quality systems in a sustainable and cost-aware manner. Typical areas of support include: • EU GMP, USP, and international GMP audit preparation • Mock inspections and independent gap assessments • QMS stabilization and remediation planning • Inspection-focused risk evaluation and prioritization • Management support from an external inspector perspective I deliberately avoid overselling, short-term fixes, and consultant dependency. The goal is always internal ownership, clarity, and inspection-robust systems that function in daily operations.
SENIOR GMP CONSULTANT | 30+ YEARS | 50+ INSPECTIONS COMPLIANCE IS NOT A PAPER EXERCISE. IT IS AN OPERATIONAL REALITY. Systems do not fail because the SOP is missing a comma. They fail because the gap between "what is written" and "what is done" becomes too wide to defend under the scrutiny of an inspector. With over 30 years of industry experience and more than 50 successful inspections (FDA, Swissmedic, EMA, Authorities), I provide the external perspective necessary to bridge that gap. I do not offer "cookie-cutter" templates; I offer structured reality. MY CORE PRINCIPLES: Anti-Overengineering: Complexity is a silent risk. A system you cannot explain simply is a system you cannot defend. Operational Ownership: Quality is a management priority. If the responsibility stays trapped in the Quality Department, the system is fragile. Audit Readiness as a Standard: Sustainable compliance is not a "sprint" before an inspection. It is the result of stable, repeatable execution. HOW I PARTNER WITH ORGANIZATIONS: I act as a strategic partner for pharmaceutical leaders who require an objective assessment of their GMP status. My value lies in identifying where systems are over-engineered and where they are genuinely at risk. Strategic Audit Preparation: Seeing your facility through the eyes of an auditor before they arrive. System Simplification: Reducing friction in GMP processes to ensure they work under pressure. Management Advisory: Aligning regulatory requirements with business objectives. I do not seek to create more documentation. I seek to create more clarity.
Consulting in all areas of GxP Carrying out of qualifications Establishment of quality management systems Implementation of international audits Trainings QA management Preparation of all GMP relevant documents GAMP 5 ALCOA+ 5S