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Brian Mccole

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Brian Mccole

Vice President, Quality Initiatives | AI Clinical Analytics within Life Sciences

United States

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Brian Mccole

Summary

Brian Mccole is a seasoned professional with extensive experience in the Life Sciences sector, currently serving as Vice President of Quality Initiatives at USDM Life Sciences. His expertise spans a wide array of quality assurance and compliance processes, particularly in navigating complex regulatory landscapes such as 21 CFR Part 11. Brian is recognized for his strategic approach to business process improvements that enhance organizational effectiveness and compliance. He has a proven track record of leading cross-functional teams and managing large-scale projects within the pharmaceutical and medical device industries. His leadership style is characterized by a commitment to governance, risk management, and compliance, making him a valuable asset in any organization. Beyond his technical skills, Brian is passionate about mentoring emerging professionals in the field. He holds a degree in Business & Engineering from Villanova University, specializing in Operations Management.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Industry-specific interests

Emerging Technologies

Leadership Development

Innovation

Organisational experience

Corporate Experience

Consulting Experience

Brian Mccole

Work Experience

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Vice President, Quality Initiatives at

AI Clinical Analytics within Life Sciences

January 2014 - Present

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QMS Practice Director at

AI Clinical Analytics within Life Sciences

January 2014 - Present

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Director, Quality Systems & Validation at

IGATE

January 2006 - January 2014

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Principal Consultant at

McCole and Associates, Inc.

January 2003 - January 2006

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Lead Compliance Consultant at

Ives Envision

January 2000 - January 2002

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Manager, ERP Consulting & Validation at

Sapbaanssacincom

January 1985 - January 2000

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Brian Mccole

Education

Villanova University, Business & Engineering

Frequently Asked Questions about Brian Mccole

What is Brian Mccole email address?

Brian Mccole's primary email address is *******@usdm.com. To view the full verified email and additional contact details, sign up for free with Muraena.

What company does Brian Mccole work for?

Brian Mccole is a Vice President, Quality Initiatives at AI Clinical Analytics within Life Sciences, a company specializing in Diagnostic substances.

Where Brian Mccole graduated from?

Brian Mccole holds a degree in Operations Management from Villanova University.

How can I directly contact Brian Mccole?

To contact Brian Mccole directly, you can use the email address *******@usdm.com. Complete contact information is available upon registration with Muraena.

Who is Brian Mccole?

Brian Mccole is a seasoned professional with extensive experience in the Life Sciences sector, currently serving as Vice President of Quality Initiatives at USDM Life Sciences. His expertise spans a wide array of quality assurance and compliance processes, particularly in navigating complex regulatory landscapes such as 21 CFR Part 11. Brian is recognized for his strategic approach to business process improvements that enhance organizational effectiveness and compliance. He has a proven track record of leading cross-functional teams and managing large-scale projects within the pharmaceutical and medical device industries. His leadership style is characterized by a commitment to governance, risk management, and compliance, making him a valuable asset in any organization. Beyond his technical skills, Brian is passionate about mentoring emerging professionals in the field. He holds a degree in Business & Engineering from Villanova University, specializing in Operations Management.

Brian`s contact details

mail

*******@usdm.com

Colleagues

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Panos Boudouvas

Cloud Compliance Advisory Board MemberCloud

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Robert Lucchesi

Vice President, Life Sciences

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Ken Shitamoto Ms

Executive Director, IT Quality and Compliance

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Diane Gleinser

VP Life Science Services and Solutions

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Justin Ott

VP Business Development

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Jeff Burton

Vice President of Sales

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Jim Macdonell

VP, Medical Device Services and Solutions

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John Petrakis

Chief AI Officer

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Vega Finucan

Co-Founder / Managing Partner

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