Head of IT Governance, Risk, Compliance

🔥 13 hours ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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LabConnect

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2002

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $24.5M Series A - LabConnect on 2017-06

Healthcare • Pharmaceuticals • Biotechnology

LabConnect is a global central laboratory solutions partner that provides technology-driven, customized, orchestrated, and scalable laboratory and data services to support clinical trials and drug development worldwide. Its offerings include central and specialty bioanalytical testing, radiopharmaceutical support, decentralized/near-home collection, custom collection kits and high-volume kitting, companion diagnostics and assay validation, data management and harmonization, regulatory and scientific project management, and commercial/post-market support. LabConnect serves sponsors and CROs across multiple therapeutic areas (oncology, vaccines, cell and gene therapy/ATMPs and more), emphasizing program oversight and operational execution for clinical research.

📋 Description

• Establish and mature LabConnect’s IT Governance, Risk, and Compliance function • Lead the strategy and operating model for AI-enabled GxP compliance • Deploy AI and agentic tooling to draft and maintain SOPs and controlled documents • Detect compliance gaps across code, configuration, infrastructure, and documentation • Define agentic development rules, policy-as-code, human review gates, and automated compliance checks • Govern AI adoption across internal workflows and product development • Establish validation, human-oversight, transparency, monitoring, and auditability standards for AI • Assess and strengthen controls across SOC 2, HIPAA, GDPR, and FDA 21 CFR Part 11 • Implement automated evidence collection and continuous control monitoring • Guide governance for access, endpoint, virtual desktop, remote-work, and BYOD environments • Strengthen data classification, monitoring, and loss-prevention controls • Evaluate third-party, vendor, service-provider, AI model, and agentic tooling risk • Partner with infrastructure, security, engineering, data, quality, operations, and business leaders • Work with the Quality team to ensure IT controls, automated evidence, and AI-assisted documentation meet validation-grade expectations

🎯 Requirements

• Bachelor’s degree in computer science, engineering, information systems, or a related field is required • 15+ years of progressive leadership experience across IT security, risk, compliance, or GRC • Accountability for a regulated control environment • Demonstrated track record of building strong teams and leading meaningful transformation • Senior executive or enterprise leadership experience with accountability for compliance strategy, organizational capability, and audit outcomes • Experience introducing AI or intelligent automation into compliance, quality, or regulated documentation workflows through adoption and auditor acceptance • Hands-on familiarity with source control, CI/CD, infrastructure-as-code, AI-assisted development, and agentic approaches • Strong grasp of data architecture and data governance, including relational, unstructured, blob, and vector-based data models • Significant experience in Microsoft Azure environments, including Purview, Entra ID, Defender, Azure Data Lake, and Azure AI services • Demonstrated audit and inspection success across SOC 2, HIPAA, GDPR, or FDA 21 CFR Part 11 • Experience in regulated industries such as healthcare, life sciences, or clinical research is strongly preferred • Strong working knowledge of SOC 2, ISO 27001, HIPAA, GDPR, 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 opportunity through the company’s bonus plan • Comprehensive benefits package