Beschreibung

I am an independent Enterprise Quality Consultant with over 20 years of hands-on leadership across global pharma, biotech and contract research organisations. I specialise in GCP, GDP, GLP and GPvP — helping pharma companies, biotech startups and CROs build inspection-ready quality functions, transform their QMS, and position quality as a strategic business advantage rather than a compliance burden.

I started my career as a practicing physician. That foundation shapes everything I do. When I talk about patient safety and data integrity, it is not regulatory language — it is personal. Every audit I conduct, every system I design, and every team I train is ultimately in service of one goal: getting safe, effective therapies to the patients who need them.

My clients typically engage me for three things: preparing for FDA, EMA or MHRA inspections with confidence; rebuilding or harmonising a QMS that has outgrown its original design; or providing senior quality leadership on a flexible project basis without the overhead of a full-time hire.

Based in Switzerland. Available globally. Fluent in the language of quality, compliance and results.

Branchenexpertise

Sprachen

Englisch
Muttersprachlich oder zweisprachig
Bulgarisch
Muttersprachlich oder zweisprachig
Italienisch
Konversationssicher
Russisch
Konversationssicher
Französisch
Grundkenntnisse

Arbeitsortpräferenzen

Vor Ort möglich

Lausanne (bis zu 50 km)

Q CONS | Quality Consultancy
Founder & Enterprise Quality Consultant
PHARMAZEUTISCHE INDUSTRIE
Januar 2025 - Heute (1 Jahr und 5 Monate)
Switzerland
▸ Independent GCP, GDP, GLP and GPvP quality consultancy serving pharma, biotech and CROs globally
▸ Delivering QMS design, inspection readiness programmes, clinical quality oversight and digital quality transformation
▸ Providing fractional Quality Director services to emerging biotech companies and small CROs on a project basis
▸ Thought leadership through published articles on inspection readiness, quality culture and integrated trial processes
GCP & Regulatory Inspection Readiness QMS Design, Harmonisation & Transformation Clinical Quality Assurance & GCP Oversight ESP & CRO Quality Oversight GxP Training Design & Quality Capability Building
Optimapharm
Senior Quality Assurance & Training Director
November 2023 - Dezember 2024 (1 Jahr und 1 Monat)
▸ Led enterprise-wide QMS transformation and GxP training infrastructure across a multi-country CRO
▸ Designed and implemented risk-based audit programmes aligned with ICH E6 R3 and evolving regulatory expectations
▸ Built and delivered bespoke GxP training curricula for clinical operations, quality and regulatory teams
▸ Strengthened inspection readiness culture through mock audits, SME coaching and governance frameworks
▸ Managed external service provider qualification and quality oversight programmes
Allucent
Director Quality Assurance & Compliance
März 2021 - November 2023 (2 Jahre und 8 Monate)
▸ Directed global QA and compliance function across multiple clinical programmes and regulatory jurisdictions
▸ Led FDA, EMA and MHRA inspection readiness programmes with zero critical findings
▸ Oversaw GCP audit programme covering sponsor oversight, CRO qualification and investigator site audits
▸ Implemented CAPA governance framework and KQI dashboard for real-time compliance performance monitoring
▸ Managed quality governance across Clinical Operations, Medical Affairs and Pharmacovigilance
▸ Led digital quality transformation including eQMS optimisation and data integrity programme