Lucy Wingett
Director, Nonclinical (GLP/GCLP) Research and Development Quality
- Role
- Director, R & d Laboratory Quality at Moderna
- Location
- Memphis, TN, US
- LinkedIn followers
- 500 followers
About Lucy Wingett
Quality and compliance professional with over 30 years of industry experience. Leader of audit teams & QMS strategy programs with a demonstrated history of working in the biotechnology & agricultural industry. Skilled in Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Computer Systems Validation and Auditing (CSV) and basic CLIA laboratory quality oversight. Subject matter expert in FDA and EPA regulations, OECD principles and GCLP guidelines.
Experience
Director, R & d Laboratory Quality
Mar 2024 — Present · Cambridge, MA, US
Education
Mississippi State University
Ornamental Horticulture
Delta State University
Bachelor of Applied Science (BASc), Biology/Biological Sciences, General Studies
1987
Skills
- Glp
- Clinical Research
- 21 Cfr Part 11
- Sop
- Fda
- Gmp
- Validation
- Pharmaceutical Industry
- Clinical Trials
- Lifesciences
- Change Control
- Quality Assurance
- Quality System
- Clinical Development
- Capa
- Gxp
- Biopharmaceuticals
- Regulatory Submissions
- Ind
- Cross-Functional Team Leadership
- Lims
- Toxicology
- Regulatory Affairs
- Drug Development
- Ctms
- V&V
- Life Sciences
- Standard Operating Procedure (Sop)
- U.s. Food and Drug Administration (Fda)
- Good Laboratory Practice (Glp)
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