Director, Digital Governance

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Take ownership of and enhance the IT Governance framework for digital platforms, emphasizing control standards and operational enforcement.

• Develop and execute technical governance controls that are integrated into the SDLC and platform delivery workflows.

• Continuously assess the effectiveness of governance by utilizing leading indicators and control health metrics, delivering valuable insights for ongoing improvement.

• Create and sustain proactive KPI dashboards to provide clarity on: adherence to technology governance, access, auditability, traceability controls, and the digital risk posture of third-party and vendor relationships.

• Facilitate Quality-led audits and inspections by providing: system-generated evidence and dashboards, traceability from governance design to execution, and coordinated, technology-focused responses to findings.

• Establish data governance frameworks that align with enterprise guidelines. Oversee the IT execution of data governance, which includes: metadata, lineage, and traceability standards in Alation, as well as data access, classification, and lifecycle controls.

• Ensure the implementation and monitoring of governance controls across platforms, ensuring that digital platforms adhere to ALCOA+ principles by design (audit trails, access controls, traceability). Identify data integrity risks through digital risk dashboards and defined escalation paths. Collaborate with Data & Analytics teams to operationalize governance via: data catalogs, stewardship models, and data quality monitoring. Act as the escalation point for data integrity risks that affect clinical, operational, or regulatory outcomes.

• Establish and implement an AI Governance framework that aligns with the enterprise's responsible AI framework. Ensure that adherence to AI governance is measurable, continuously monitored, and enforceable. Integrate governance into AI lifecycle processes (design, development, deployment, monitoring) in collaboration with Architecture, Development, Security, and Quality teams. Govern both vendor-provided and internally developed AI capabilities.

• Lead the IT Governance, Data Governance, and AI Governance councils, ensuring consistent decision-making across digital domains.

• Assist in IT inspection readiness, including: preparation of evidence and traceability, governance documentation, and KPI dashboards, as well as coordinated IT responses during regulatory and sponsor inspections. Collaborate with Quality on CAPA remediation related to: IT systems, data integrity, and technology-enabled processes.

⛳️ Requirements

• Bachelor’s degree in Information Systems, Computer Science, Engineering, or a related field.

• Over 10 years of experience in IT governance, regulated technology environments, data governance, or enterprise risk.

• Proven experience working within GxP-regulated clinical, biotech, pharmaceutical, or healthcare environments.

• Demonstrated hands-on experience in authoring, maintaining, and operationalizing IT SOPs and controlled documents within a regulated setting.

• Ability to define, build, and operate KPI-driven governance dashboards effectively.

• Strong expertise in Data Governance, with a history of establishing governance frameworks, policies, and controls to ensure data quality, integrity, and compliance.

• Familiarity with AI Governance concepts, including exposure to Responsible AI frameworks in regulated settings is a plus, with an expectation to quickly develop proficiency on the job.

• Capability to clearly communicate complex governance and risk topics to executive leadership, regulators, and non-technical stakeholders.

• Proven ability to operate effectively in matrixed organizations, influencing outcomes without direct authority.

• Experience collaborating with Quality during inspection responses, remediation of findings, and CAPAs related to data integrity.

🏝️ Benefits

• Comprehensive benefits to support physical, mental, and financial well-being.