LabConnect
LabConnect

LabConnect supports clinical trials and drug development as a global central laboratory solutions partner. The company combines central and specialty bioanalytical testing with radiopharmaceutical services, decentralized and near-home sample collection, custom collection kits, companion diagnostics, assay validation, and laboratory data management.

Its teams help sponsors and contract research organizations coordinate complex research programs across areas including oncology, vaccines, and cell and gene therapy. LabConnect also provides data harmonization, regulatory and scientific project management, and commercial and post-market support, with an emphasis on translating laboratory operations into reliable execution throughout the clinical research lifecycle.

Head of IT Governance, Risk and Compliance - Remote Tennessee

Lead LabConnect’s IT governance, risk, and compliance strategy for healthcare research operations, with a focus on AI-enabled GxP compliance. Oversee privacy, security, regulated AI, and continuous control monitoring.

Description

  • Build and advance LabConnect’s IT Governance, Risk, and Compliance function
  • Shape the strategy and operating model for AI-enabled GxP compliance
  • Use AI and agentic tools to create and maintain SOPs and controlled documents
  • Identify compliance weaknesses across code, configuration, infrastructure, and documentation
  • Set standards for agentic development, policy-as-code, human review, and automated compliance testing
  • Oversee AI adoption across internal processes and product development
  • Define AI standards for validation, human oversight, transparency, monitoring, and auditability
  • Evaluate and enhance controls covering SOC 2, HIPAA, GDPR, and FDA 21 CFR Part 11
  • Establish automated evidence gathering and continuous control monitoring
  • Direct governance for access, endpoints, virtual desktops, remote work, and BYOD environments
  • Improve data classification, monitoring, and loss-prevention measures
  • Assess risks related to third parties, vendors, service providers, AI models, and agentic tools
  • Collaborate with infrastructure, security, engineering, data, quality, operations, and business leaders
  • Partner with the Quality team to ensure IT controls, automated evidence, and AI-supported documentation satisfy validation-grade expectations

Requirements

  • Bachelor’s degree in computer science, engineering, information systems, or a related discipline is required
  • At least 15 years of progressive leadership experience in IT security, risk, compliance, or GRC
  • Experience owning a regulated control environment
  • Proven success building high-performing teams and delivering significant transformation
  • Senior executive or enterprise leadership experience overseeing compliance strategy, organizational capability, and audit results
  • Experience implementing AI or intelligent automation in compliance, quality, or regulated documentation workflows, including adoption and auditor acceptance
  • Practical knowledge of source control, CI/CD, infrastructure as code, AI-assisted development, and agentic methods
  • Strong understanding of data architecture and governance across relational, unstructured, blob, and vector data models
  • Extensive experience with Microsoft Azure, including Purview, Entra ID, Defender, Azure Data Lake, and Azure AI services
  • Successful audit and inspection experience involving SOC 2, HIPAA, GDPR, or FDA 21 CFR Part 11
  • Experience in healthcare, life sciences, clinical research, or another regulated industry is strongly preferred
  • Working knowledge of SOC 2, ISO 27001, HIPAA, GDPR, the NIST AI Risk Management Framework, and ISO/IEC 42001
  • Knowledge of GxP, FDA 21 CFR Part 11, computer system validation, and risk-based computer software assurance

Benefits

  • Annual incentive eligibility through the company bonus plan
  • Comprehensive benefits package

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