Strategic Excellence in Global Quality Systems.
Specialized in the strategic development of global quality systems and the execution of rigorous international auditing programs. We ensure your organization remains inspection-ready and compliant with global health authorities.
Quality Management Systems
Full-scale architecture and end-to-end implementation of comprehensive Quality Management Systems (QMS) for pharmaceutical and medical device organizations.
Strategic design of corporate quality frameworks, ensuring seamless integration of all regulatory requirements while maintaining full client ownership.
Leading the digital transformation of quality landscapes, from the initial roadmap to the successful deployment of eQMS and Document Management Systems (DMS).
Development and optimization of the entire regulatory documentation hierarchy, including Site Master Files (SMF), Quality Management Manuals (QMH), and core SOP landscapes.
High-level coaching and strategic advisory for quality leadership to ensure internal teams are empowered to maintain and evolve the system independently.
Technical Operations
Strategic oversight of qualification and validation life cycles for complex manufacturing equipment, sterility testing isolators, and cleanroom facilities (Classes A to D).
Advisory on the design and implementation of contamination control strategies (CCS) and environmental monitoring programs in highly regulated environments.
Expert guidance on cleaning validation, process validation, and Method Transfer Management (MTM) to ensure robust and reproducible results.
Critical assessment of Data Integrity frameworks (ALCOA+) and GAMP5 requirements to secure the digital and physical integrity of manufacturing data.
Technical coaching for internal teams to manage computerized systems and automated processes according to the latest international standards.
Auditing & Diagnostics
Execution of a full spectrum of audits, including internal, external, and third-party assessments across global markets.
Systematic initiation through in-depth GAP analyses and Mock Audits to evaluate the maturity and integrity of existing quality systems and processes.
Strategic identification of compliance risks and operational weaknesses to establish a realistic baseline for remediation.
Lead auditor expertise in managing and hosting high-stakes inspections by international authorities such as FDA, Swissmedic, and EMA.
Development of targeted action plans and remedial measures to ensure sustainable inspection readiness and regulatory alignment.
Interim Management & Strategic Restructuring
Operational Stability through Expert Integration
When organizational growth or regulatory challenges demand immediate action, I provide decisive interim leadership to restructure quality departments and ensure stability. My approach goes beyond temporary gap-filling; I bridge the divide between operational activities and complex regulatory requirements during critical transition phases.
The Goal: Sustainable Independence Consistent with my inspection-oriented approach, the focus is never on creating dependency. Responsibility and ownership of the GMP system remain fully within your organization at all times. My role is to act as an independent assessor and advisor, providing targeted support to enable a smooth and reliable handover to your internal team.
Built to Last A GMP system only succeeds if it remains robust long after external support has ended. Through continuous knowledge transfer and the pragmatic allocation of tasks, I ensure that your quality processes are not just compliant on paper, but are understood, owned, and lived by your staff in daily practice.