I am a Management Systems leader with extensive experience implementing a wide range of Management Systems—including Quality, Information Security, AI, Automotive, Document, and Learning—across multiple industries. Over the course of my career, I have frequently integrated and harmonized overlapping management systems, ensuring they work together efficiently while meeting business objectives and regulatory requirements.

With years of hands-on experience, I can “translate” regulatory and compliance requirements across diverse sectors—from life sciences (GLP, GCP, GMP, GDP, GPvP) to information security (ISO 27001, NIST 800-53), to automotive (IATF 16949), and beyond to teams that are not versed in such. I also specialize in the emerging field of AI Management Systems (AIMS), applying frameworks such as ISO/IEC 42001 and global AI regulatory guidance to ensure trustworthy, ethical, and compliant use of AI within regulated industries.

My mission is to lead companies—regardless of industry—through Quality, Security, and Digital transformations using a pragmatic “keep it simple” methodology. I believe management systems should be tailored to company size, resources, and capabilities, while always protecting customer trust, product/service quality, and data integrity.

Effective management systems don’t need to be complex—they need to be practical, scalable, and resilient. This applies equally to traditional compliance domains and the safe, compliant integration of AI.

Areas of Expertise

 

Electronic Systems

  • Veeva Quality Suite

  • Master Control

  • Compliance Wire

  • TrackWise

  • Documentum

  • Atlassian Confluence and JIRA

  • Tenable W.A.S

  • SafeBase (Trust Centers)

  • SumoLogic SIEM

  • TrendMicro

  • Apple Business Essentials

  • Wizer

  • OLLAMA

  • V0

  • Replit / Claude

Quality Management

  • Document Management

  • Exception Management (QE/CAPA) & RCA

  • Change Controls

  • GxP Training

  • GxP Vendor Management

  • GxP Auditing (Internal/External)

  • Product Complaints

  • Risk Assessments / Management

  • Batch Record Review

  • Literature Review Processes

Information Security + Privacy

  • Enterprise Governance, Risk and Compliance (GRC)

  • ISMS Implementation / Support / Guidance

  • ISMS Change and Risk Management / Assessment

  • ISMS Document Management, Training, Auditing, Gap Assessments

  • SOC 2 Type II Compliance and Support

  • Vulnerability Tracking and Management

Ai

  • AI Management System Implementation / Support / Guidance

  • EU AI Act

  • Ollama Installation and LLM Configuration

Systems Implementation, Validation and Security

  • System implementation (e.g. Veeva, MasterControl), testing and Go Live activities of Quality Systems including project management, “right-sizing” configuration, migration, roll out, administration and training activities.

  • Software Development Life Cycles including development and documentation of:

    • Agile / Waterfall Development

    • URS/FRS

    • Configuration Specifications

    • Traceability Matrices

    • Validation Protocols, IQ/OQ/PQ, and Summary Reports

  • Amazon Web Services

  • Security Controls (ISO 27001, GDPR, Penetration/Vulnerability Testing)

GxP Modalities

  • GLP

  • GCP

  • GMP

  • GPvP

Regulations/Standards

  • 21 CFR parts 11, 210, 211, 314, 803 and 820

  • FDA CSA + CSV

  • EMA Annex 11

  • ERES (JP)

  • HIPAA - 45 CFR part 160/164

  • ICH Q7, Q9 and Q10

  • EU Ai Act

  • GAMP 5 (Compliance and Testing)

  • ISO

    • 9001:2015

    • 13485:2016

    • 19011:2018

    • 27001:2022

    • 42001:2023

    • 90003:2018

  • NIST 100-1 (Ai RMF 1.0)

  • NIST 800-53 (SOC2 Type II) + HIPAA

  • VPAT

Awards

 

Panels and Publications

Panelist: Veeva Quality Summit 2018:

  • 5 June 2018 (note - original website has since been removed, link is to historical web page via Internet Archive)

  • Topic: “Technology Considerations and Recommendations Before Embarking on a Quality Transformation Project”

Whitepaper: “Quality Management and Validation in Pharmacovigilance Software”:

  • March 2018

Publication: Pharmaceutical Information and Pharmacovigilance Association- Co-Author – Issue 55: “Quality Management and Validation in Pharmacovigilance Software”:

  • April 2018

  • Note - Original Whitepaper drafted was adapted by Tessa Heffernan and submitted for publication.

Resources