Michelle Holbrook Email & Phone Number | A well respected business leader and Quality Assurance (QA) professional with the experience and capabilities to manage an international team of QA auditing professionals and skills to develop annual audit plans relative to Good Clinical Practices (GCP), Good Laboratory Practice (GLP) and Pharmacovigilance (GVP) audits. A qualified professional with wide ranging experience in varying types of GCP, Computerized Systems Practices (CSV) and GVP auditing, training, and consultancy. Extensive experience in Standard Operating Procedure (SOP), Corrective and Preventative Actions (CAPA) development and Risk-Based planning and decision making gained through increasing positions of responsibility in the pharmaceutical industry.

Michelle Holbrook

A well respected business leader and Quality Assurance (QA) professional with the experience and cap...
Raleigh, North Carolina, United States

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Michelle Holbrook’s Location Raleigh, North Carolina, United States

Michelle Holbrook’s Current Industry Stemline Therapeutics

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Executive Director, Quality Assurance GCP

2023-11-01 00:00:00 - Present

Senior Director

2022-07-01 00:00:00 - 2023-11-01 00:00:00

Director, R&D QA, blue bird bio

2020-09-01 00:00:00 - 2021-11-01 00:00:00

Vice President

2015-10-01 00:00:00 - 2020-09-01 00:00:00

Head of Business

2013-09-01 00:00:00 - 2015-10-01 00:00:00

Senior QA Auditor

2009-08-01 00:00:00 - 2012-07-01 00:00:00

Senior QA Auditor

2005-01-01 00:00:00 - 2009-01-01 00:00:00

QA Auditor

2004-01-01 00:00:00 - 2005-01-01 00:00:00

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Michelle Holbrook is a A well respected business leader and Quality Assurance (QA) professional with the experience and capabilities to manage an international team of QA auditing professionals and skills to develop annual audit plans relative to Good Clinical Practices (GCP), Good Laboratory Practice (GLP) and Pharmacovigilance (GVP) audits. A qualified professional with wide ranging experience in varying types of GCP, Computerized Systems Practices (CSV) and GVP auditing, training, and consultancy. Extensive experience in Standard Operating Procedure (SOP), Corrective and Preventative Actions (CAPA) development and Risk-Based planning and decision making gained through increasing positions of responsibility in the pharmaceutical industry.

Michelle Holbrook has prior
experience in the following industries:
2seventy Bio | Bluebird Bio | Fda Quality And Regulatory Consultants | Adamas Consulting | Rho | Kendle International | Ppd

Michelle Holbrook has the following professional experience:
Stemline Therapeutics | 2seventy Bio | Bluebird Bio | Fda Quality And Regulatory Consultants | Adamas Consulting | Rho | Kendle International | Ppd