LeadInternalAuditor–GlobalQualityM/F/D

## **Job Description** **Role Overview** The Lead Internal Auditor within the Customer Quality & Compliance team is responsible for planning, leading, and executing risk‑based internal audits within regulated medical devices and pharmaceutical environments. This role serves as a subject matter expert in quality system and regulatory auditing, ensuring compliance with applicable global regulations and standards while driving continuous improvement of the Quality Management System (QMS). This individual will be part of the broader Global Quality Organization. The primary focus of the role is the **regulated internal audit program**. In addition, the role provides **secondary support for inspection readiness activities** , working in close collaboration with Quality, Regulatory, and site leadership teams. **Primary Responsibilities – Lead Internal Audit** * Lead and **conduct risk-based internal audits** across pharmaceutical and medical device operations in line with the approved audit schedule. * Serve as**Lead Auditor** for complex, cross-functional, and multi-site audits, overseeing planning, execution, reporting, and follow-up. * Assess QMS compliance and effectiveness against**ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements.** Develop audit strategies, plans, and reports, communicating findings, trends, and improvement opportunities to stakeholders. * **Identify systemic issues** and drive continuous improvement initiatives across the QMS. * **Provide guidance** on the interpretation and application of regulatory and quality requirements while maintaining auditor independence. * Train and coach sites on self-directed audits to support the Internal Audit Program with appropriate oversight. **Secondary Responsibilities – Inspection Readiness & Notified Body Support** * Support **inspection and audit readiness activities** to maintain a state of ‘Always Audit Ready.’ * Assist with preparation for **regulatory authority inspections and Notified