DTE Audit & Compliance Manager; Sr. Principal Analyst

Job Description

The Audit & Compliance Manager manages and coordinates audit, inspection, and compliance activities across Data, Technology & Engineering (DTE) and business functions. This role serves as the primary liaison between operational teams and auditors, ensuring timely preparation, execution, response, and remediation of Internal Audits, GxP audits, and regulatory inspections. The role partners closely with Internal Audit, Quality Assurance, SOX PMO, system owners, and business teams to ensure audit commitments are met and compliance obligations are fulfilled.

Serve as the primary DTE point of contact for IT-related audit, inspection, and compliance requests across GxP, Internal Audit, and operational audit activities. Coordinate audit and inspection preparation activities, including stakeholder readiness, request management, evidence collection, and response tracking. Facilitate communication between DTE teams, business stakeholders, Quality Assurance, Internal Audit, SOX PMO, and external auditors or inspectors. Track audit findings, observations, CAPAs, management responses, action plans, and remediation commitments through closure.

Oversee the compliance metrics dashboard, including ongoing enhancements to monitor audit readiness, remediation progress, compliance trends, and leadership objectives. Promote consistent audit preparation, evidence management, documentation, and remediation practices across DTE.

Support GxP audit and regulatory inspection readiness activities in alignment with quality and compliance expectations. Participate in Process Owner Network discussions regarding GxP compliance, risk, and continuous process improvement opportunities. Support health authority inspections and inspection readiness programs, including preparation of DTE SMEs and stakeholders.

Coordinate IT-related internal operational audit activities for DTE. Support audit walkthroughs, testing activities, and auditor communications.

Drive assigned remediation/CAPA activities to timely closure. Lead remediation meetings and provide clear status reporting on open actions, risks, and closure plans. Monitor closure commitments and elevate at-risk deadlines.

Analyze trends in audit findings, inspection observations, remediation activities, and control performance. Provide audit readiness metrics, remediation updates, and compliance status reporting to leadership. Drive ongoing improvements to dashboard content, metrics, and reporting processes to meet leadership objectives for compliance visibility, accountability, and decision-making.

Provide guidance on audit expectations and compliance requirements. Identify opportunities to improve audit processes and inspection readiness. Support audit management tools and governance processes. Contribute to training and awareness activities related to GxP, audits, and inspections. Promote consistency in audit preparation, evidence management, and remediation practices across DTE. Partner with the SOX PMO to identify process and control improvement opportunities where the SOX program intersects with overall DTE compliance efforts.

5–8+ years of experience in IT Compliance, Quality, Internal Audit, SOX, GxP Compliance, or a related field. Experience supporting audits, inspections, and remediation activities in regulated environments. Working knowledge of GxP, CSV/CSA, 21 CFR Part 11, SOX, NIST SP 800-53, GDPR, General IT Controls, and audit methodologies. Experience overseeing contractors and managed service provider work. Experience developing…