Michelle Frese

Trailblazer
DISC Type : DI

Sr Manager Quality Systems & Compliance at Belite Bio

San Francisco, California, United States

Overview

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.

Personality Overview

Achievement-Oriented

Assertive

Values Relationships

They like to keep things under control.  They will bat for you if they come to believe in you. They do not mind taking risks and can make hard decisions, if necessary.

Topics They Care 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.
Document Control
Expertly manages end-to-end document control processes for all GxP documentation, including lifecycle management, periodic reviews, and change control coordination.

Media Appearances

Michelle has no verified media appearances

Work History

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

Education

6-2024 - 10-2026
Bachelors of Science from City College of San Francisco
2024 - 2026
Bachelors from City College of San Francisco

More Information

Social Presence :

Prographics :

Exp : 9 Location : San Francisco, California, United States Job Level : Middle Designation : Sr Manager Quality Systems & Compliance at Belite Bio
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Insights For Selling To Michelle

During A Call Or A Meeting

DO's

  • Build a trustworthy relationship while keeping the product center-stage
  • Give them control of the sales process
  • Keep your pitch focused on the impact but nurture the relationship too

DONT's

  • Do not look like someone who doesn’t know what they are talking about
  • Don’t force involvement of other stakeholders unless it is critical
  • Don’t hesitate from asking them how they truly feel about your product

When Cold Calling

When Writing An Email

While Negotiating & Closing

    The secret to closing fast with Michelle is

  • Relationship and product conviction matter equally, followed by a sense of achievement.
  • Will you ever get a clear answer from Michelle

  • If they are not convinced, they will say no albeit in a friendly manner.


Insights For Deal Planning

    How fast (or slow) will Michelle move?

  • They can make decisions quickly if they develop trust in you and conviction in the product.
  • Can Michelle take some risk or not?

  • They can take risks if necessary.

You And Michelle

Personality Compatibility


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