Tien Lai Email & Phone Number
Senior Director, Quality and Regulatory Compliance @ BrightInsight
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Tien Lai Location
- Austin, TX, US
Tien Lai Work
- 2026 -now Senior Director, Quality and Regulatory Compliance @
- 2024 -now Director of Compliance @
- 2023 -2024 Clinical Compliance Manager @
- 2022 -2023 Regulatory Affairs Specialist III @
- 2021 -2022 Quality Engineer III @
- 2019 -2021 Senior Quality Systems Engineer @
- 2018 -2019 Audit Consultant @
- 2018 -2019 Senior Quality Assurance Associate @
- 2016 -2018 Quality Assurance Auditor @
- 2012 -2015 Lead Quality Assurance Specialist @
- 2011 -2012 Practice Manager @ Advanced Orthopaedics and Sports Medicine Institute
Tien Lai Education
- Eastern University College of Business and Leadership
Master of Business Administration - MBA, Organizational Management (Biology/Biological Sciences, General)
- George Mason University
Bachelor of Science (B.S.), Biology/Biological Sciences, General
- Eastern University
Master of Business Administration - MBA (Organizational Management)
Tien Lai Skills
- Clinical Quality
- Audit Management
- Management Review
- Team Leadership
- Quality Compliance
- Global Regulatory Compliance
- Strategic Planning
- Collaborative Problem Solving
- Professional Development Programs
- Clinical Compliance
- Clinical Affairs
- Regulatory Compliance
- Quality System Compliance
- Cross-functional Team Leadership
- Risk Management
- GxP Audit
- Teamwork
- 21 CFR
- EU MDR
- ISO Standards
- MDSAP
- In Vitro Diagnostics (IVD)
- Communication
- Product Development
- Clinical Laboratory Improvement Amendments (CLIA)
- Medical Devices
- Supplier Quality Management
- External Audits
- Good Manufacturing Practice (GMP)
- Pharmaceutical Manufacturing
- Continuous Process Improvement
- Good Clinical Practice (GCP)
- Internal Audits
- Analytical Skills
- Microsoft Office
- Microsoft Excel
- Microsoft Word
- PowerPoint
- Management
- Leadership
- Training
- Process Improvement
- Project Management
- Validation
- Investigation
- Quality Assurance
- Quality Control
- Microsoft Project
- Quality Management System
- ISO 14971
- ISO 13485
- Design Control
- Auditing
- Quality Management
- Corrective and Preventive Action (CAPA)
Tien Lai Summary
- Tien Lai, based in Austin, TX, US, is currently a Senior Director, Quality and Regulatory Compliance at BrightInsight. Tien Lai brings experience from previous roles at Prelude, Edwards Lifesciences and Natera. Tien Lai holds a Master of Business Administration - MBA, Organizational Management in Biology/Biological Sciences, General @ Eastern University College of Business and Leadership. With a robust skill set that includes Clinical Quality, Audit Management, Management Review, Team Leadership, Quality Compliance and more. Tien Lai has 3 emails and 2 mobile phone numbers on RocketReach.
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Senior Director, Quality and Regulatory Compliance
Austin, TX, US
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