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Q&A With Richard Hughes

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Richard Hughes
principal consultant, Scendea
Location: Kensington, MD United States
Joined: Oct 17th, 2024

About (request update)

Education (request update)

University of Maryland System class of 2027

Undergrad Major: Management

- College Not Listed - class of 0

Grad Major:

Experience

I currently work with Scendea as principal consultant
I have years of experience working in the Consulting Services industry.

CEO Lead Quality Consultant | Enabling Pre-clinical Quality LLC
From January 2016 to Current • 10 year(s)
Provided quality assurance and secondary oversight across diverse industries including environmental, agricultural, medical devices, biologics, and industrial chemicals. Established strategic partnerships and guided regulatory compliance efforts for clients including Precision for Medicine, PsychoGenics, Veristat, FDA, USDA, TDMI, and J&J.

Senior Manager, Quality Compliance | Pharmaron CPC, Inc
From June 2023 to July 2024 • 1 year(s)
Conducted routine reviews of compliance protocols while coaching team members through training and audit programs. Oversaw GCP quality assurance processes for clinical trials and ensured adherence to IRB and PI-approved protocols.

Director of Quality Assurance | Amador Bioscience, Inc
From May 2021 to March 2023 • 2 year(s)
Led QA operations across global sites ensuring compliance with FDA, EMA, MHLW, Chinese Ordinance 34, and other regulatory bodies. Spearheaded implementation of a global QMS aligning quality systems with regulatory requirements.

Manager Good Laboratory Practice and Research Quality Assurance | AstraZeneca/MedImmune
From April 2007 to December 2015 • 8 year(s)
Directed GLP compliance and research quality assurance initiatives, evaluating team performance against regulatory standards. Implemented secondary review program for quality oversight of human biological specimens and WHO GCLP quality oversight.

Contract Auditor | Quality Associates Inc.
From August 2006 to April 2007 • 1 year(s)
Ensured compliance with FDA GLP standards for nonclinical laboratory studies at Boehringer Ingelheim. Provided oversight for EPA regulations under FIFRA, EPA TSCA, and FDA GLP while generating comprehensive audit reports.

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