Alexander Valenca Email
Director, GRA Device Regulatory Lead for Specialty Care and Vaccine Combination Products @ Sanofi
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Alexander Valenca Location
- Germany
Alexander Valenca Work
- Director, GRA Device Regulatory Lead for Specialty Care and Vaccine Combination Products @ (July 2023 - Present)
- Director Quality and Regulatory Compliance - Global Quality Device Development @ (January 2020 - July 2023)
- Device Development Quality Operations - Global Quality Systems and Compliance Head @ (July 2017 - January 2020)
- Team Leader Regulatory Compliance (Medical Device Development) @ (May 2015 - July 2017)
- Team Leader Quality Systems and Quality Project Management (Medical Device Development) @ (August 2013 - May 2015)
- Quality Project Manager Medical Devices @ (April 2011 - August 2013)
- QA Manager Medical Decives @ (November 2008 - April 2011)
- Lab Manager Analytics @ InfraServ GmbH & Co. Knapsack K.G. (October 2002 - October 2008)
Alexander Valenca Education
- Marburg University
Dr. rer. nat. / PhD (Physical Chemistry)
1998-2002 - Justus Liebig University Giessen
Diploma (Chemistry)
1990-1997
Alexander Valenca Skills
- 21 CFR Part 11
- Analytical Chemistry
- CAPA
- Change Control
- Computer System Validation
- Corrective and Preventive Action (CAPA)
- Cross-functional Team Leadership
- Design Control
- EU Medical Device Regulations
- FDA
- GMP
- ISO 13485
- Medical Device Software
- Medical Devices
- Mobile Applications
- Mobile Devices
- Pharmaceutical Industry
- Polymer Physics
- Polymer Science
- Product Development
- Quality Assurance
- Quality Management
- Quality System
- Regulatory Affairs
- Software Development
- Standard Operating Procedure (SOP)
- Surface Analysis
- U.S. Food and Drug Administration (FDA)
- V&V
- Validation
- Verification and Validation (V&V)
- Computer System
- Corrective and Preventive Action Capa
- Customer Service
- Cross Functional Team Leadership
- Process Improvement
- Healthcare
- u.s. Food and Drug Administration Fda
- Standard Operating Procedure Sop
- Verification and Validation V&V
- Standard Operating Procedure
- u.s. Food and Drug Administration
- Verification and Validation
- Corrective and Preventive Action
Alexander Valenca Summary
- Alexander Valenca, based in Germany, is currently a Director, GRA Device Regulatory Lead for Specialty Care and Vaccine Combination Products at Sanofi. Alexander Valenca brings experience from previous roles at Sanofi. Alexander Valenca holds a 1998 - 2002 Dr. rer. nat. / PhD in Physical Chemistry @ Marburg University. With a robust skill set that includes 21 CFR Part 11, Analytical Chemistry, CAPA, Change Control, Computer System Validation and more. Alexander Valenca has 2 emails on RocketReach.
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