Lynnzi le Email & Phone Number
Director, Product Quality Leader @ Gilead Sciences
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Lynnzi le Location
- New York, NY, US
Lynnzi le Work
- Director, Product Quality Leader @ (May 2025 - Present)
- Director, Biologics External Quality @ (December 2022 - May 2025)
- Assoc. Director, Biologics CMC Quality- QPL @ (January 2021 - December 2022)
- Associate Director, Biologics External Quality and Quality Product Lead (QPL) @ (April 2019 - January 2021)
- Sr. Manager, Small Molecules External Commercial Quality @ (February 2017 - April 2019)
- Global Quality and Compliance Manager @ (December 2014 - February 2017)
- Product Quality Lead @ (January 2014 - November 2014)
- Sr. Quality Operations and Validation @ (January 2006 - December 2013)
- Sr. QA Validation @ (January 2005 - November 2005)
- Validation Consultant @ (January 2003 - January 2004)
- Validation Consultant @ (January 2001 - January 2003)
- Analyst @ (January 2000 - January 2001)
Lynnzi le Education
- Kean University
B.S. (Tennis)
- Seton Hall University School of Law
Graduate Certificate (Pharmaceutical and Medical Device Law and Compliance)
Lynnzi le Skills
- Validation
- V&V
- CAPA
- FDA
- Quality Assurance
- Change Control
- Pharmaceutical Industry
- Biotechnology
- Quality System
- SOP
- 21 CFR Part 210 & 211
- 21 CFR Part 11
- GAMP
- Computer System Validation
- Process Validation
- Cleaning Validation
- Quality Control
- Aseptic Processing
- Regulatory Affairs
- LIMS
- Chromatography
- Quality Management
- HPLC
- GCP
- GLP
- GxP
- Regulatory Requirements
- Regulatory Submissions
- Cross-functional Team Leadership
- Biopharmaceuticals
- Vaccines
- Biologics
- Technology Transfer
- Analytical Chemistry
- Quality Auditing
- Trackwise
- Software Documentation
- USP
- EP
- JP
- Deviations
- Vendor Management
- Supplier Qualification
- Supplier Risk Management
- Compliance Management
- cGMP practices
- U.S. Food and Drug Administration (FDA)
- Standard Operating Procedure (SOP)
- Corrective and Preventive Action (CAPA)
- Good Laboratory Practice (GLP)
- Operations Management
- Corrective and Preventive Action Capa
- Regulatory Audits
- Supply Chain
- Product Quality
- Maximo
- Interfaces
- Project Management
- Phase Ii
- Scorecard
- Quality Operations
- Right First Time
- Operations
- APIs
- QC
- Regulatory Agencies
- EPA
- Cross Functional Team Leadership
- Good Laboratory Practice Glp
- Decommissioning
- Schedules
- Cfr
- Technical Transfers
- Components
- Technical Operations
- Commitments
- Reviews
- Transformations
- Maintenance
- SharePoint
- OOS
- Trend Analysis
- Test Data
- Metrology
- Training
- Chemistry
- Process Improvement
- Testing
- cGMP manufacturing
- Cod
- Ammonia
- Documentation
- Pharmaceutical Sales
- Small Molecules
- Data Verification
- Resolutions
- GMP
- Design
- Laboratory Equipment
- Contractors
- Third Party Vendors
- Data Validation
- u.s. Food and Drug Administration Fda
- Fashion
- Liaison
- Networking
- Analytical Skill
- Vendors
- Grease
- Microsoft Office
- Quality Improvement
- Specifications
- Packaging
- Oversight
- Manufacturing
- Keys
- Capital Projects
- CMC
- Decision Making
- House
- Functional Requirements
- Business Continuity
- Timelines
- Risk Management
- Strategic Planning
- Template
- Commissioning
- Team Leadership
- 21 Cfr Part 210 and 211
- Oncology
- Distillation
- Investigation
- Laboratory
- Metrics
- Inspection
- Protocol
- SAP
- Records
- Adherence
- Supply
- Statistics
- Microsoft Word
- Calibration
- Batch Records
- Statisticians
- Commercial Products
- Daily Operations
- CMOS
- SQL
- Service Providers
- Titration
- Conductivity
- Reporting
- Observation
- Tests
- Sales
- Suppliers
- Standard Operating Procedure Sop
- Plateau
- Leadership
- Raw Materials
- u.s. Food and Drug Administration
- Corrective and Preventive Action
- Good Laboratory Practice
- Standard Operating Procedure
Lynnzi le Summary
- Lynnzi le, based in New York, NY, US, is currently a Director, Product Quality Leader at Gilead Sciences. Lynnzi le brings experience from previous roles at Gilead Sciences, Bristol Myers Squibb and Celgene. Lynnzi le holds a B.S. in Tennis @ Kean University. With a robust skill set that includes Validation, V&V, CAPA, FDA, Quality Assurance and more. Lynnzi le has 2 emails and 1 mobile phone numbers on RocketReach.
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