Magdalena Wrycza-Sklarow

Magdalena Wrycza-Sklarow has extensive work experience in quality assurance and regulatory compliance. Magdalena currently works at Ascensia Diabetes Care as a Senior Quality Audit Lead, responsible for overseeing audits and providing guidance. Prior to this role, they worked as a Quality Systems Specialist at Ascensia, where they coordinated cross-functional teams and ensured compliance with European regulations and global requirements. Magdalena also served as an External Expert in the Medical Devices Division at Polskie Centrum Badan i Certyfikacji S.A. Magdalena previously held positions at BLIRT S.A. as a Quality Assurance Specialist and Management Board Representative, and at Medicover Integrated Clinical Services as a Quality Assurance Manager and QA Team Leader. Magdalena began their career as a Medical Laboratory Technician and later worked as a Clinical Research Coordinator at Synevo Central Labs and SYNEVO. Magdalena's experience spans over 20 years and includes expertise in quality management systems, regulatory intelligence, and internal and external audits.

Magdalena Wrycza-Sklarow's education history is as follows:

From 2018 to 2019, they attended Jagiellonian University and pursued a degree in the Pharmaceutical Department. Their field of study focused on Clinical Trials on Medicinal Products.

In 2008 and 2009, they studied at Gdańsk University of Technology and obtained a Diploma in Quality Management. Their field of study centered around ISO standards and TQM (Total Quality Management).

From 2001 to 2006, they pursued their Master's degree at the University of Gdańsk. Their degree was in Computer Science and Econometry.

In 1995 and 1997, they attended the Medical College in Gdańsk and obtained a Diploma in Laboratory Diagnostics. The specific field of study is not provided.

In addition to their formal education, Magdalena Wrycza-Sklarow has obtained several certifications throughout their career. These certifications include being an IRCA Certified Lead Auditor ISO 13485:2016 from BSI (obtained in March 2022), completing MDSAP: Fundamentals and Readiness Training from BSI (obtained in December 2021), becoming an Internal Auditor ISO 13485:2016 from Ms Consulting (obtained in October 2020), obtaining the Certfied Internal Auditor SZJ ISO 9001:2015 certification from SGS (obtained in June 2019), becoming a Certfied Internal Auditor ISO 15189:2008 from Polskie Centrum Badan i Certyfikacji S.A. (obtained in November 2011), and completing a training course on Computer Systems Validation based on GAMP4/FDA; CFR 21 Part 11 from PL Consultancy (obtained in November 2004).