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EXPERTEN

FÜR IHRE PROJEKTE

Dr. Yvette Schollmeier

Yvette Schollmeier, a Biochemist by heart, brings a unique blend of curiosity and drive to enhance her surroundings. Passionate about Quality & Compliance, she possesses a robust background in the Pharmaceutical and MedTech industries. Yvette's expertise encompasses the entire spectrum of Quality Management Systems, ranging from analytical laboratories to the digitalization of GXP processes.

In her roles as Director Quality Management, Chief Quality Officer, and Commercial Quality Manager, Yvette has successfully led projects, including QMS (both paper-based and digital) implementation, Audit readiness initiatives, New Product Introduction (NPI) projects, and fast track applications in the pharmaceutical sector. She has served as a product owner and technical transfer lead, demonstrating her ability to navigate diverse challenges.

With extensive experience in Audit Management, Yvette, a TÜV certified Auditor, has conducted first-, second-, and internal-audits. Her proficiency extends to supporting third-party audits by various authorities such as FDA, EMA, China, and Mexico. In her diverse Quality Management roles, she provided oversight for GLP, GCP, and GMP settings, managed SOP portfolios, DMS (document management system), LMS (learning management system) and ensured compliance across organizational and supplier processes.

Beyond Quality topics, Yvette has contributed to start-ups with Regulatory Support, bridging the gap between quality and regulatory aspects, including PSUR, general reporting and supporting Pharmacovigilance (PV) system setup. 

In her commitment to positive change, Yvette offers a comprehensive portfolio of Quality & Compliance Management, all backed by a solid scientific foundation.

Yvette Schollmeier

Expert's Profile

Chapter: DE Members

Stakeholder Expertise

Biotech | Providers - Healthcare | MedTech | Pharma – Ethical | Pharma – Orphan | Science / Associations | Startups

Functional Expertise

Development | Health Tech | Medical | Pharmacovigilance/Safety | Quality | Regulatory | Research

Process Expertise Tools

Business Development | Change Mgmt | Innovation | Proj / Program Mgmt

Market Expertise

Europe | Germany | USA

Contact

Käfertaler Str. 21
69123 Heidelberg

Phone: +49 179 749 8057

Website

Social Media

LinkedIn