DTE Audit & Compliance Manager (Sr. Principal Analyst)
Core
Manage and coordinate audit, inspection, and compliance activities for Data, Technology & Engineering (DTE) functions, serving as the primary liaison between operational teams and auditors to ensure timely preparation, execution, and remediation of Internal Audits, GxP audits, and regulatory inspections.
Role type
Senior IC compliance and audit manager
Builds
Audit readiness programs, compliance metrics dashboards, and remediation action plans
Domain
Biotechnology / Regulatory Compliance (GxP, SOX, IT Controls)
Deliverable
dashboards & analysis
Required skills
GxP compliance, SOX compliance, IT audit coordination, regulatory inspection readiness, CAPA management, compliance metrics analysis, project management, IT service management
Preferred skills
Contractor oversight, risk mitigation strategy, audit process improvement
Technologies
NIST SP 800-53, CSV/CSA, 21 CFR Part 11, GDPR
Responsibilities
Coordinate audit and inspection preparation including stakeholder readiness and evidence collection; Track audit findings, observations, and remediation commitments through closure; Analyze trends in audit findings and control performance; Provide compliance status reporting to leadership; Lead remediation meetings and monitor closure commitments; Facilitate communication between DTE teams, Quality Assurance, Internal Audit, and external auditors.
Seniority
Senior, hands-on IC