Andrea Harmsen
Highly experienced and well rounded Quality Management Professional, creative and curious
- Role
- Head of Quality Operations Cluster at Sanofi
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Andrea Harmsen
Ambitious, enthusiastic, hands on QUALITY MANAGEMENT Professional with strong LEADERSHIP skills.Over 25 years QA and sterile Manufacturing experience in different Pharmaceutical, Medical Devices and Diagnostics companies in US and Germany
Experience
Head of Quality Operations Cluster
Jan 2023 — Present · MA, US
Supporting our External Manufacturing Entities in North America and Latam in all aspects of Quality Managememt and Quality Assurance Additional I am responsible for deployment of a new Sanofi Quality System throughout External Manufacturing and Supply
Education
University of Applied Sciences, Düsseldorf (Germany)
Master's degree, Diplome Process Engineering (in German: "Diplom Ingnieur")
1992 — 1996
Skills
- • Expertise in Gmp, QA and Legal Requirements
- Capa, Deviation, Cc, Sop, Training
- Audits (Eu Authorities, Fda, Clients, Internal)
- Cleaning Validation, Process Valdation, Mediafill, Qualification Iq, Oq, Pq,
- Team Leadership
- Cross-Functional Team Leadership
- Highly Motivated Self-Starter
- Learning Quickly
- Persures Gools with Great Persistence and Reach Very Good Results
- Great Motivator
- Collaboration Over Cross Functional Teams
- Infectious Ethusiasm Person
- Open, Co-Operative, Supportive
- • Native German, Fluent English
- Capa
- Fda
- Gmp
- Pharmaceutical Industry
- Quality Control
- Validation
- 21 Cfr Part 11
- Biopharmaceuticals
- Biotechnology
- Quality Assurance
- Quality System
- Sop
- Technology Transfer
- Standard Operating Procedure (Sop)
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.