Michelle Frese in

Michelle Frese

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Sr Manager Quality Systems & Compliance at Belite Bio
📍 San Francisco, California, United States

Michelle Frese is a Sr. Manager of Quality Systems with 20 years of experience in the biotechnology, life sciences, and medical device sectors. She specializes in implementing and managing electronic quality management systems, ensuring compliance with ISO and GxP standards. Colleagues describe her as capable, dependable, and collaborative.

She recently obtained an ACE Essentials Core certification and completed an Audit and Supplier course at the MasterControl Master Summit 2024.

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Experience
9 Years
Current Role
Sr Manager Quality Systems & Compliance
Job Level
Middle
Location
San Francisco, California, United States
Personality Overview

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Communication Style
Decision Approach
Work Preference

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Priorities

Topics Michelle cares about

Quality System Management
Oversees the implementation and global management of electronic quality systems like EDMS, QMS, and LMS, with specific experience in Veeva and MasterControl.
Biotech Compliance
Possesses extensive knowledge of key industry standards and regulations, including ISO 9001, 13485, GxP, cGMP, and 21 CFR Part 11.
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Career

Work history

12-2025
Sr Manager Quality Systems & Compliance
Belite Bio
7-2025 - 12-2025
Sr Manager, External Quality and Product Release
Sangamo Therapeutics, Inc.
12-2023 - 7-2025
Sr. Manager, Quality Systems
Prothena Corporation
1-2023 - 12-2023
Sr. Manager, Quality Systems
Sangamo Therapeutics, Inc.
2-2020 - 1-2023
Quality Systems Manager
Sangamo Therapeutics, Inc.
In the press

Media appearances

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Education
6-2024 - 10-2026
Bachelors of Science
City College of San Francisco
2024 - 2026
Bachelors
City College of San Francisco
Social presence
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Behavioral profile

DISC profile (public)

DISC behavioral profile

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