Dennis Chan
Quality & Compliance Manager | Cell & Gene Therapies, Antibody-Drug Conjugates, Monoclonal Antibodies | Quality Operations, QMS, CSV Expert | Lean Six Sigma Black Belt
- Role
- Regional Ecompliance Manager at Novartis
- Location
- Morristown, NJ, US
- LinkedIn followers
- 500 followers
About Dennis Chan
As a Quality Leader at Novartis, I lead and support the implementation and maintenance of quality and compliance standards across the region. I collaborate with cross-functional teams and external partners to ensure the delivery of high-quality products and services that meet the regulatory requirements and customer expectations.With 10 years of experience in biopharmaceutical (monoclonal antibodies, antibody-drug conjugates, cell & gene therapies) and consumer healthcare, I have developed expertise in quality operations, quality management systems (QMS), and computerized system validation (CSV). I have also obtained multiple certifications in clinical trials operations and product management, and contributed to several process improvement and risk management initiatives. I hold bachelor\'s degrees in Cell Biology and Neuroscience, and Psychology from Rutgers University. I am passionate about drug development and eager to apply my skills and knowledge to advance the field.
Experience
Regional Ecompliance Manager
Dec 2022 — Present · Morris Plains, NJ, US
SPOC for eCompliance Center of Excellence located in Europe and Asia
Education
Rutgers University
Bachelor's degree, Cell Biology and Neuroscience
Rutgers University
Bachelor's degree, Psychology
Skills
- U.s. Title 21 Cfr Part 11 Regulation
- Biopharmaceuticals
- Monoclonal Antibodies (Mabs)
- Technical Writing
- Neuroscience
- Stability Programs
- Biotechnology
- Cold Chain
- Cell Biology
- Quality Assurance
- Pharmacy
- Good Laboratory Practice (Glp)
- Pharmaceutical Industry
- Batch Records
- Specifications
- Etq
- Inventory Management
- Change Control
- Raw Materials
- Customer Service
- Microsoft Excel
- Quality Control
- Gmp
- Life Sciences
- Risk Assessment
- Cross-Functional Coordination
- Biochemistry
- U.s. Health Insurance Portability and Accountability Act (Hipaa)
- Biologics
- Compliance
- 21 Cfr
- Consumer Products
- Standard Operating Procedure (Sop)
- Supplier Management
- Microsoft Word
- Microsoft Office
- Quality Systems
- Continuous Process Improvement
- Change Management
- Data Analysis
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