Michelle W. Lee in

Michelle W. Lee

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Associate Director, R&D Quality Operations and Excellence - Process and Procedure Lead at BeOne Medicines
📍 United States

A cross-functional biotechnologist from UC Berkeley and the University of Sydney, Michelle leads R&D Quality Operations at BeOne Medicines. She specializes in GCP regulations and quality systems, driving process improvements and ensuring compliance across all phases of drug development. Her expertise spans both early-stage R&D and late-stage clinical trials.

Driven by her Masters in International Public Health, Michelle is passionate about connecting scientific innovation with global patient needs. She champions building advocacy for collaborative stakeholder partnerships, aiming to ensure that technical R&D pursuits translate into tangible health solutions for communities around the world, particularly in underserved areas.

She previously managed a global health program focused on accelerating R&D for neglected tropical diseases like malaria and tuberculosis.

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Experience
15 Years
Current Role
Associate Director, R&D Quality Operations and Excellence - Process and Procedure Lead
Job Level
Mid-senior
Location
United States
Personality Overview

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Priorities

Topics Michelle cares about

Clinical Quality Assurance
Leads R&D Quality Operations, overseeing GCP guidance, Quality Management System implementation, and regulatory compliance across all drug development phases.
Global Health Equity
Managed programs to accelerate R&D for neglected diseases and improve cancer care access in Africa, reflecting a core passion for global health solutions.
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Career

Work history

8-2024
Associate Director, R&D Quality Operations and Excellence - Process and Procedure Lead
BeOne Medicines
3-2023 - 8-2024
Senior Manager, GCP Clinical Quality Assurance - Internal Process Audit Lead
BeOne Medicines
7-2021 - 3-2023
Manager, GCP Clinical Quality Assurance- Vendor Management and Oversight
BeiGene
10-2019 - 7-2021
Senior Clinical Quality Specialist
BeiGene
1-2019 - 8-2019
Program Manager
BIO Ventures for Global Health
In the press

Media appearances

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Education
2013 - 2014
Master's degree
University of Sydney
2002 - 2006
Bachelor of Science
University of California, Berkeley
Social presence
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Behavioral profile

DISC profile (public)

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