AUDIT PROGRAM MANAGER - QUALITY ASSURANCE

Job Title: Audit Program Manager - Quality Assurance Our client is a prominent national company in the healthcare sector. We are seeking a qualified professional for the following role: Role Description: Responsible for compliance activities related to the Internal Audit Program. Conducts internal audits and audits at suppliers/contractors to ensure adherence to regulatory standards and Quality System requirements. Supports the identification and implementation of improvements to the Quality System. Main Responsibilities: Planning and execution of internal audits and audits at production sites and commercial affiliates across Europe. Identifying compliance risks and supporting improvement plans. Preparing the annual audit plan and reporting results. Leading initiatives to address regulatory gaps, including CAPA development. Supporting Inspection Readiness activities. Participating as an expert in audits. Coordinating cross-functional projects and promoting change. Maintaining up-to-date knowledge of global regulations. Requirements: Degree in a scientific or technical field (biology, chemistry, engineering, medical technology, quality management). At least 5 years of experience in regulated sectors (pharmaceutical or medical devices). Knowledge of GMP, ISO 13485, 21 CFR 820/600, IVDD. Training in audit techniques; Auditor certification preferred. Knowledge of the IVD diagnostic sector (preferred). Fluent in English; German is a plus. Willingness to travel up to 75% of the year. Additional Information: Direct employment offer. Remote work location. This opportunity is open in compliance with Legislative Decree 198/2006 and Legislative Decrees 215/2003 and 216/2003. Interested candidates are invited to read the privacy policy in accordance with Articles 13 and 14 of EU Regulation 2016/679. Authorization Min. Prot. N. 1207 SG dated 16/12/2004 J-18808-Ljbffr

Location: provincia-di-latina, IT

Posted Date: 6/26/2025