Shabana Hameed
- Role
- Head Gastrointestinal & Inflammation Clinical Qa, R & d Quality at Takeda
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Shabana Hameed
Award-winning Medical Device and Pharma Quality Leader with 20+ years of experience in…
Experience
Head Gastrointestinal & Inflammation Clinical Qa, R & d Quality
Mar 2023 — Present
Strategic GCP and quality leadership for drug development programs, partnering closely with key R&D leaders and R&D Quality
Education
Iowa State University
Ph.D, Environmental Science (Statistics minor)
1994 — 1999
Skills
- Process Improvement
- Cross-Functional Team Leadership
- Quality Management
- Regulatory Submissions
- U.s. Food and Drug Administration (Fda)
- Quality Assurance
- Validation
- Nb and Ca Inspections
- Organizational Development
- Iso 14155
- Dmaic
- Iso 14971
- Quality System Remediation
- Trend Analysis
- Medical Devices
- Change Management
- Ich E6
- Market Development
- Management
- 21 Cfr
- Iso 13485
- Quality System and Clinical Audits
- Quality System
- Corrective and Preventive Action (Capa)
- Capa
- Data Analysis and Reporting
- Design Control
- Spc
- V&V
- Fda
- Qsit and Bimo Inspections
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