Richard Hughes
Kensington
Summary
Dynamic Quality Assurance Leader with extensive experience at Pharmaron CPC, Inc., specializing in regulatory compliance and quality management systems. Demonstrated success in cross-functional leadership and clinical trial oversight, ensuring strict adherence to GCP and GLP standards. Highly skilled in risk management and continuous improvement initiatives, driving operational excellence across complex environments. Committed to enhancing quality frameworks to support organizational goals.
Overview
18
18
years of professional experience
Work History
Senior Manager, Quality Compliance
Pharmaron CPC, Inc
Baltimore
06.2023 - 07.2024
- Conducted routine reviews of compliance protocols alongside rigorous training and audit programs.
- Managed compliance audits to ensure standards adherence.
- Oversaw GCP quality assurance processes for ISF, TMF, and Source Data requirements.
- Inspected clinical trials to confirm adherence to the latest IRB and PI-approved protocols.
- Ensured the delivery of current and precise information about investigational products to the PI.
- Ensured the safety and well-being of all participants through meticulous management of adverse events (AEs) and serious adverse events (SAEs).
- Ensured reliability in research through meticulous matching of source data to CRFs.
- Oversaw administration and disposition processes for investigational products.
- No instances of debarment occurred among investigators and sub-investigators.
- Ensured that FORM FDA 1572 includes investigators and sub-investigators without financial conflicts of interest.
- Investigators, sub-investigators, research nurses, pharmacists, and laboratory personnel have state or federal licensure qualifications, completed sponsor-delivered, study-specific training.
- Ensured investigators and sub-investigators completed required educational credentials.
- Validated licensure qualifications for investigators, sub-investigators, research nurses, pharmacists, and laboratory personnel.
- Ensured completion of required educational credentials for investigators and sub-investigators.
Director of Quality Assurance
Amador Bioscience, Inc
Pleasanton
05.2021 - 03.2023
- Directed QA operations across global sites, ensuring compliance with FDA, EMA, and other regulatory bodies
- Spearheaded the implementation of a global QMS, aligning quality systems with regulatory requirements for product development and lifecycle management
- Worked cross-functionally to ensure alignment between regulatory strategies and overall business goals
CEO Consultant
Enabling Pre-clinical Quality LLC.
Kensington
01.2016 - 06.2021
- Provided quality assurance and secondary oversight for noncontiguous medical devices, small molecules, biologics, pesticides, and industrial chemicals.
- Provided tertiary oversight to organizations in the environmental, agricultural, medical devices, small molecules, and biologics industries.
- Established strategic partnerships and guided regulatory compliance efforts.
- The client list includes Precision for Medicine, PsychoGenics, Veristat, the FDA, TDMI, and J&J.
Manager Good Laboratory Practice and Research Quality Assurance
AstraZeneca/MedImmune
Gaithersburg
04.2007 - 12.2015
- Administered GLP compliance and research quality assurance initiatives.
- Ensured regulatory compliance and quality standards through coordination with international teams.
- Implemented a secondary review program for quality oversight of human biological specimens.
- Evaluated procedures for handling biological specimens to ensure compliance with safety standards.
- Performed thorough inspections to sustain equipment performance.
- Managed state credentials staff with training records.
- Implemented WHO GCLP quality oversight, including a secondary review program.
- Assured that state or federal authorities licensed qualified laboratory personnel, analytical methods were validated, lab technicians maintained, calibrated, and qualified (PQ) the performance of the laboratory instruments, and documented quality control samples.
Contract Auditor
Quality Associates Inc.
Fulton
08.2006 - 04.2007
- Ensured compliance with FDA GLP standards for nonclinical laboratory studies at Boehringer Ingelheim.
- Provided are the Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA Toxic Substance Control Act (TSCA), and FDA GLP oversight for ADME studies.
- Generated comprehensive audit reports.
- Confirmed the Pre-Manufacture Notices for EPA evaluations on human and environmental risks.
- Conducted thorough documentation review for chemicals under TSCA evaluation.
- Ensured standard operating procedures are accurate, current, and followed consistently.
- TSCA Chemical Substances Inventory precisely tracks all chemicals that are used and produced.
- Ensured compliance with FIFRA standards on all label components.
- Monitored and maintained operational equipment efficiency.
Education
Bachelor of Science - Laboratory Management
University of Maryland
Largo, MDSkills
- Regulatory Strategy & Compliance (FDA, EMA, ICH, GCP, GLP, GMP)
- Cross-functional Leadership & Stakeholder Engagement
- Quality Management System (QMS) Development & Implementation
- Clinical Trial Oversight & Ethical Compliance (21 CFR Part 50)
- Risk Management
- CAPA
- Continuous Improvement
- GxP Facility Design
- Validation
- Quality Audits
- Regulatory compliance
- Quality management
- Risk assessment
- Clinical trial oversight
- Data management
- Training program development
- Standard operating procedures
- Compliance monitoring
- Stakeholder engagement
- Documentation and reporting
- Property storage management
Accomplishments
- Established a 10K SQ FT Bioanalytical Laboratory near FDA facilities, ensuring GLP compliance and operational efficiency.
- Played a pivotal role in transforming a clinical pharmacology firm into a multinational GLP/ISO 17025-compliant CRO.
- Led the development of global SOPs compliant with FDA, OECD, MHLW, and China Ordinance 34, streamlining regulatory processes across multiple regions.
- Directed EPA GLP quality assurance at Dupont Haskil Laboratory, overseeing compliance with environmental regulations and ensuring the integrity of toxic substance studies.
Additional Information
The most important work I have ever done was the year of EPA GLP QA oversight I provided at the Dupont Haskil Laboratory. This is because of the assumed benefit vs. risk everyone understands what they take part in when taking a medication voluntarily. Still, we all are the subjects of 'clinical trials' for pesticides and toxic substances, and no one ever imagines they are risking their lives when they choose a salad.
Licenses Certificates Training
10/01/21, RQAP-GLP, SQA
Activities
Salutatorian - General Education Development Program, District of Columbia, 06/08/89
Timeline
Senior Manager, Quality Compliance
Pharmaron CPC, Inc
06.2023 - 07.2024
Director of Quality Assurance
Amador Bioscience, Inc
05.2021 - 03.2023
CEO Consultant
Enabling Pre-clinical Quality LLC.
01.2016 - 06.2021
Manager Good Laboratory Practice and Research Quality Assurance
AstraZeneca/MedImmune
04.2007 - 12.2015
Contract Auditor
Quality Associates Inc.
08.2006 - 04.2007
Bachelor of Science - Laboratory Management
University of Maryland
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