Independent Consultant

Yvette Schollmeier

Quality and Compliance Consultant

Dr Yvette Schollmeier is a TÜV-certified auditor and quality and compliance consultant for the pharmaceutical, biotechnology and medical device industries.

Certifications

  • Dr. rer. nat. Biochemistry, University of Heidelberg
  • TÜV-certified QM Auditor (ISO 19011:2018)
  • TÜV-certified QM Manager (Six Sigma white belt level)
  • TÜV-certified QM Representative (ISO 9001:2015)
  • TÜV-certified Compliance Officer (ISO 19600)
  • TÜV-certified QM for the Medical Device Industry (ISO 13485)
  • GCP SpecialistCertified Business Manager
  • Project Management Workshops (PMM fundamentals, PMC I)
  • LEAN Management Workshop

Dr Yvette Schollmeier is a TÜV-certified auditor and quality and compliance consultant with experience in the pharmaceutical, biotechnology and medical device industries. Her expertise includes quality management systems (QMS), GMP, GCP, regulatory compliance, supplier oversight and audit readiness.

She has held senior roles including Chief Quality Officer and Director of Quality Management. She designs and optimises quality systems, leads inspection readiness programmes and translates complex regulatory requirements into practical, risk-based solutions. She has supported organisations in meeting FDA, EMA and international regulatory expectations. She works in German and English.

Selected projects include the introduction of a global digital QMS and the set-up of a QMS for a group of countries. She has managed new product introductions for a pharmaceutical and a medical device, and qualified suppliers and contract manufacturers through audits.

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