Jenny Gallo
Controlled Substance Compliance | DEA Compliance | Audits | Compliance Training | Inspection Management
- Role
- Associate Director, Dea Compliance at Teva Pharmaceuticals
- Location
- Fort Lauderdale, FL, US
- LinkedIn followers
- 500 followers
About Jenny Gallo
Experienced (15+ years) Senior Compliance Manager with a demonstrated history of working in the pharmaceutical industry. 12+ years of experience in DEA Controlled Substance Compliance, with a successful inspection record.
Experience
Associate Director, Dea Compliance
Aug 2022 — Present · Miami-Fort Lauderdale, FL, US
Responsible for the development and maintenance of the corporate DEA Compliance training program •Oversees 5 physical sites and 16 DEA registrations •100% inspection success rate (no observations or administrative action from DEA)•Manages and coaches a successful team of two direct reports•Lead a multi-functional vault capacity team, which increased the useable space in the vault by 30%•Responsible for maintaining DEA compliance at a site with over 60% controlled product activity•Fully reconciles and reports 22 different compounds twice a year•Participated in and received an OPEX yellow belt certification•Consistently implements lean processes in all aspects of DEA compliance•Actively participates in the success of the site as a whole with a role on the extended leadership team •Successfully mentored the DEA compliance team through a 5S of their workspace and processes•Maintains a transparent and healthy working relationship with the DEA local office•Performs internal audits of other Teva sites and helps them become compliant and successful•Promotes teamwork and improvements throughout the site through Gemba and Process Confirmation•Provides growth and development opportunities for direct reports (a well-developed team is a successful team!)
Education
Florida International University
Master of Science - MS, Forensic Science and Technology
2007 — 2009
Michigan State University
Bachelor of Science - BS, Chemistry
2003 — 2007
Skills
- Dea Compliance
- Empower
- Xrf
- Scanning Electron Microscopy
- Karl Fisher
- Microsoft Office
- Controlled Substance Management
- Controlled Substance Ordering and Distribution
- Chemistry
- Controlled Substances Act
- Headspace Gc
- 21 Cfr Part 1300 to End
- Tlc
- Chromatography
- Validation
- Mass Spectrometry
- Hplc
- Titration
- X-Ray Diffraction Analysis
- Uv/Vis
- Gc-Ms
- Arcos Reporting
- Td-Gc-Ms
- Gas Chromatography
- HR-Icp-Ms
- Analytical Chemistry
- Mae
- Ftir
- Toxicology
- Yers Reporting
- Icp-Ms
- Glp
- Laboratory
- Solid Phase Extraction
- Usp/Nf Raw Material Testing
- Chemstation
- Dissolution
- High-Performance Liquid Chromatography (Hplc)
- Quality Control
- Gmp
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