Heather Groves

About Heather Groves

I work at the intersection of Technology Compliance, Quality Systems, and AI Governance in life sciences and regulated healthcare. My focus is on building and governing global compliance systems that support automation, analytics, and responsible AI adoption without compromising inspection readiness.I bring deep experience across GxP systems, enterprise audit programs, CSV/CSA, data integrity, and technology governance, partnering closely with IT, Legal, Product, and operational teams. I’m known for translating regulatory complexity into practical, defensible processes that scale in high-change environments.In recent years, my work has centered on AI governance and enablement, including AI system audits, policy development, and human-in-the-loop controls for AI-assisted quality processes. I currently serve as a Technology QA liaison for AI-related audit and inspection readiness, helping organizations adopt AI responsibly within regulated frameworks.I believe compliance should enable innovation, not obstruct it. Strong governance isn’t bureaucracy; it’s prevention, trust, and foresight.

Experience

1. Technology Compliance Manager, Qa

   Parexel

   Feb 2022 — Present

   AI Enablement- Lead Technology QA governance for regulated systems and platforms, including cloud-based and AI-enabled technologies, supporting global compliance and inspection readiness- Serve as the Technology QA liaison for AI-related audit and inspection considerations, bridging business use cases, AI teams, and regulatory expectations- Design and direct enterprise-level audits of AI systems, assessing governance, risk controls, and organizational readiness- Support escalation and formalization of enterprise AI governance policy.Quality Assurance Management- Act as QA Lead in audit programs where Technology QA representation is needed, including conducting audits for internal and external systems, IT security, and suppliers- Provide peer review feedback for colleagues\' audit reports- Participate in Serious Breach discussions as needed- Review technology-adjacent SOPs and provide feedback and suggested revisions- Regularly review the regulatory landscape for regulations or guidance that could impact the organization and provide feedback on the potential implications for the organization (i.e, perform regulatory intelligence activities).Regulatory, Client and Cross-Functional Relationships- Partner with regulatory authorities and clients to identify and mitigate issues- Support regulatory inspections and client audits as needed- Serve as a bridge between various parts of the organization, translating technical regulatory requirements into easy-to-understand concepts.Process Improvement-Identify and drive process improvements across technology and quality functions.Training and Development- Provide training to staff on topics relevant to the organization, including GxP, data integrity, and AI.

Education

• Belmont Abbey College

  Bachelor's degree, Psychology

• The University of North Carolina at Chapel Hill

  Master of Information Science - MIS