AUDIT PROGRAM MANAGER - QUALITY ASSURANCE

JR Italy; Latina; Remoto; EUR 50.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading company in the healthcare sector is seeking an Audit Program Manager - Quality Assurance. The role involves conducting internal audits and ensuring compliance with regulatory standards while implementing improvements to the Quality System. Candidates should have a relevant degree and at least 5 years of experience in regulated sectors, with fluency in English and travel flexibility.

Competenze

• Degree in biology, chemistry, engineering, medical technology, or quality management.
• At least 5 years of experience in regulated sectors (pharmaceutical or medical devices).
• Training in audit techniques; Auditor certification preferred.

Mansioni

• Planning and executing internal audits and audits at production sites across Europe.
• Identifying compliance risks and supporting improvement plans.
• Preparing the annual audit plan and reporting results.

Conoscenze

GMP

ISO 13485

21 CFR 820/600

Audit techniques

Fluency in English

Knowledge of IVD diagnostic sector

Formazione

Degree in a scientific or technical field

Descrizione del lavoro

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