Germany
Senior Quality Auditor (GMP) with 33 years of experience in the pharmaceutical industry, specializing in supplier auditing, manufacturing processes, clean utilities, and compliance. I have conducted 200+ successful internal and external audits across Europe, North Africa, and India, including complex aseptic and sterile operations. I bring a strong ability to evaluate risks, drive continuous improvement, manage quality systems, and collaborate across global teams. As Local Management System Owner, I oversee the qualification and performance monitoring of 280+ external partners across multiple sites. Known for my reliability, openness, and accountability, I aim to deliver consistent high‑quality results while continually developing my expertise. My career reflects a long‑standing commitment to operational excellence, regulatory compliance, and supportive team leadership.
Conduct up to 25 audits per year for suppliers, contract labs, and service providers (EU‑ACE scope). Assess CAPA responses and provide coaching to team members. Manage supplier oversight for 280 qualified external parties across three sites. Lead audit planning, supplier risk assessments, and qualification activities. Implemented the GoTrack Supplier Qualification module on site. Negotiate and maintain Quality Agreements with external partners.
Management of clean utilities (Water for injection, higly purified water, purified water, softened water, clean steam) quality system for Saint Priest and Gerland site Clean utilities SME Release of raw materials External management
Clean utilities system owner Management of water system Contractor Tender management in support of Procurement
Formateur Biofilm et bio contamination des eaux ultra pures
Clean utilities manager of Gerland site