Sabine Snaar, PhD, RAC -DRUG
Principal
QA/RA Consultant
Personal Profile
Experienced strategic thinker in the areas of cell therapies, biologics, and medical devices. Established track record of successful accelerated pathway applications, product development and product approvals. Excellent scientific writing skills. Strategic contributions to regulatory road maps and product approvals. Extensive experience in implementing, maintaining and operating of quality systems. Enjoy working as part of the team with the client and propelling the company to the next regulatory stage, e.g. by presenting complex situations in a convincing manner to regulatory authorities.
Specializations
- Cell and Gene Therapy
- Biologics, Blood Products, and Vaccines
- Combination products
- QA Management (GMP, G(C)LP, ICH-GCP, ISO13485)
- Analytical method development and validation
- Regulatory due diligence
- MDR
- CMC
- Training
Certifications
-
RAC (Drugs)
- ICH-GCP certification
- LRQA certified ISO 9001 auditor
- Quality by Design
- Various GMP / GDP training courses
SABINE SNAAR
Professional Experience
Principal QA/RA Consultant
Signifix | 2020 – present
Sr. QA/RA Consultant
Signifix | 2019 – 2020
Founder & QA/RA Consultant
Sabine Snaar QA Consultancy
| 2017 – 2018
QA Director
ProFibrix BV (The Medicines Company / Mallinckrodt, Pharmaceuticals )
| 2010 – 2017
QA Officer
OctoPlus | 2007 – 2009
Manager QSHE / Compliance Officer
Sanquin Blood Bank | 2006 – 2007
Sr. Project Associate QA
Xendo | 2002 – 2006
Project Associate QA
Sanquin Blood Bank
| 2001 – 2002
Clinical Research Associate
MSource | 2000 – 2001
SABINE SNAAR
Academic Education
Leiden University, Faculty of Medical Sciences
PhD in Medicine – Molecular Cell Biology
| 1996 – 2000
Thesis: “Visualization and analysis of RNA processing”
Leiden University, Faculty of Mathematics and Natural Sciences
Master of Science, Chemistry
| 1991 – 1996
Leiden University, Faculty of Social Sciences
Undergraduate degree, Psychology
| 1999 – 2001
Sabine Snaar
Publications
A number of publications in peer reviewed scientific journals.
