Jim MacDonell
VP at USDM Life Sciences
- Role
- VP, Medical Device Services and Solutions at USDM Life Sciences
- Location
- Fernandina Beach, FL, US
- LinkedIn followers
- 500 followers
About Jim MacDonell
Senior manager responsible for solution development, business development, program and project management of IT, Regulatory and Product Identification services for the Pharmaceutical Industry.
Experience
VP, Medical Device Services and Solutions
Oct 2012 — Present · US
Business, program, sales and project management.Solution and services development.Focused on UDI, DSCSA, Quality Systems, Validation and Healthcare Providers.USDM Life Sciences is the leading global technology consulting firm focused on digital transformation, regulated and unregulated data management and compliance solutions for the world’s leading and emerging biotechnology, pharmaceutical and medical device companies.
Education
University of Notre Dame
B. S., Industrial Engineering
1970 — 1974
Rutgers University
MBA, Management
1983 — 1984
Skills
- Gmp
- Program Management
- U.s. Title 21 Cfr Part 11 Regulation
- Lifesciences
- Pharmaceutical Industry
- Business Process Improvement
- Process Improvement
- Change Management
- Validation
- 21 Cfr Part 11
- Project Management
- Corrective and Preventive Action (Capa)
- Six Sigma
- Life Sciences
- Business Development
- Medical Devices
- Capa
- Consulting
- Quality Assurance
- Cross-Functional Team Leadership
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