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1330021

About: I’m a Quality and Compliance Executive Leader with more than 20 years of experience in GxP related operations and global Quality Management Systems across biopharma, biotech and medical device companies. My background spans the full GxP spectrum—from clinical development support to commercial distribution—so I’m very comfortable building quality capabilities in organizations that are growing quickly and need scalable, risk-based systems. In my recent roles, I’ve led global QA organizations, established and improved QMS frameworks, and managed inspection readiness with authorities such as FDA, Swissmedic, EMA-affiliated agencies and MEB. I’ve also overseen suppliers and contractors' qualification programs, performed GMP-GDP audits as Lead Auditor, and supported operational teams to ensure the right level of QA integration and facilitating market commercialization. I’m particularly strong at building quality foundations in moving environments. At Santen and Hoya, for example, I implemented new QMS structures, harmonized Quality Documentation systems, and designed global training programs that significantly increased compliance maturity. Through consulting roles, I’ve also supported biotech and pharma clients in developing new operating models, conducting QMS gap assessments, and implementing digital quality systems and AI powered solutions.