Helene Janzen
Bonn,NW
Summary
Result-driven Global Complaint Manager with over 4 Years of experience in enhancing product quality and customer satisfaction. Demonstrated expertise in developing and implementing effective complaint management strategies, ensuring compliance with regulatory requirements and driving significant process improvements. Expert in cross-functional collaboration, with exceptional organization and problem solving skills and a strong commitment to maintain the highest standard of customer service excellence.
Overview
27
27
years of professional experience
Work History
Global Complaint Manager
Bayer AG
01.2020 - Current
- Oversight of receipt, investigation and resolution of customer complaints ensuring regulatory compliance, driving process improvements, analyzing data for trends, and collaboration with different functions to enhance customer satisfaction and product quality
QA CMC Manager
Bayer AG
04.2012 - 12.2019
- Preparation of CMC Documentation for new drug or other regulatory submissions
Coordinating Pharmacist
Bayer AG
09.2010 - 03.2012
- Managing clinical drug supply for various clinical trials using (Interactive Response Management System) IRMS
Pharmacist
Neue-/Mühlenhof Apotheke
04.2008 - 08.2010
- Managed high volume of prescriptions daily while maintaining excellent customer service and attention to detail.
- Laboratory Management, Preparation of anticancer drugs chemotherapy medicine
Pharmacology Technologist
Harvard Cancer Center
08.2004 - 01.2006
- Development and Validation of HPLC methods
Internship /Pharmacist
Stern-/Sonnen-/Alte Apotheke
04.1997 - 03.2003
- Training “Fachapotheker für Allgemeinpharmazie”
- Development and supervision of specialized disease management for patients with chronic diseases
Education
Master of Drug Regulatory Affairs -
Rheinische-Friedrich-Wilhelms-University
2016
Fachapotheker Für Allgemeinpharmazie -
Landesapothekerkammer Baden Württemberg
2008
Licensed Pharmacist -
Rheinische-Friedrich-Wilhelms-University
1998
Skills
- Leadership
- Cross-Functional Teamwork and collaboration
- Organization and Time Management
- Verbal and written communication
- Training skills (Process and System related)
- System skills: Dev@Com, Dataone, Veeva Vault, Valgenesis, ValDevOps, PharmDoss, IRMS
Languages
German
Bilingual or Proficient (C2)
English
Advanced (C1)
Russian
Advanced (C1)
Timeline
Global Complaint Manager
Bayer AG
01.2020 - Current
QA CMC Manager
Bayer AG
04.2012 - 12.2019
Coordinating Pharmacist
Bayer AG
09.2010 - 03.2012
Pharmacist
Neue-/Mühlenhof Apotheke
04.2008 - 08.2010
Pharmacology Technologist
Harvard Cancer Center
08.2004 - 01.2006
Internship /Pharmacist
Stern-/Sonnen-/Alte Apotheke
04.1997 - 03.2003
Master of Drug Regulatory Affairs -
Rheinische-Friedrich-Wilhelms-University
Fachapotheker Für Allgemeinpharmazie -
Landesapothekerkammer Baden Württemberg
Licensed Pharmacist -
Rheinische-Friedrich-Wilhelms-University
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