Marie G.
- Role
- Manager, Clinical Quality Assurance at Jazz Pharmaceuticals
- Location
- Pottstown, PA, US
- LinkedIn followers
- 500 followers
Healthcare & Human ServicesView LinkedIn profile
About Marie G.
Clinical Quality Assurance Leader | Global Regulatory Compliance Strategist | Remote…
Experience
Manager, Clinical Quality Assurance
May 2023 — Present
Education
Rutgers University
BA, History
1993 — 1997
Walden University
Doctor of Philosophy (PhD), Public Health / Epidemiology
2008 — 2022
Skills
- Management
- Epidemiology
- Software Quality Assurance
- Change Control
- Pharmaceutical Industry
- Public Health
- Good Clinical Practice (Gcp)
- Quality System
- Computer System Validation
- Software Documentation
- Quality Auditing
- Compliance Audits
- Regulatory Requirements
- Standard Operating Procedure (Sop)
- U.s. Title 21 Cfr Part 11 Regulation
- Clinical Trials
- Documentation
- Good Documentation Practice
- Cross-Functional Team Leadership
- Clinical Research
- Sop
- Pharmacoepidemiology
- Clinical Development
- Public Speaking
- Vendors
- Regulatory Affairs
- Ctms
- Pharmaceutics
- Life Sciences
- Fda
- Quality Assurance
- Software Development Life Cycle (Sdlc)
- U.s. Food and Drug Administration (Fda)
- Computer Systems Validation
- Auditing
- Project Management
- 21 Cfr Part 11
- Vendor Qualification
- Validation
- Quality Management
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