Biologist by training with a specialization in quality, I have spent more than 20 years in the field of drug development ( e.g. biologics, recombinant, gene therapy ) from early to late phase.
Experienced Quality Assurance Manager, I have extensive expertise in developing and managing Quality Management Systems, vendor qualification, conducting audits, and managing inspections in both US & EU.
I am deeply involved in operations, with a strong focus in CMC activities, ensuring product compliance and quality throughout development. In my current role, I’ve expanded my expertise to include QA oversight for clinical trials, with a strong focus on patient safety, regulatory compliance, and the supervision of nonclinical activities like pharmacology, GLP studies, and bioanalysis.
I bring strong communication skills to build clear, open connections with internal and external stakeholders, ensuring projects stay aligned with strategic goals and regulatory requirements. I’m committed to maintaining high quality standards while offering practical, solution-focused proposals to move projects forward.
My strengths include my dynamism, my flexible, hands-on approach and a constant curiosity that pushes me to learn and grow.
