Senior GCP Quality Assurance Auditor (Hybrid Milan)

Phidealive Srl; Bardi; Ibrido; EUR 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

Phidealive is seeking an experienced Quality Assurance professional with solid expertise in Good Clinical Practice (GCP) and clinical research. The successful candidate will support the oversight and continuous improvement of Phidealive’s Quality Management System and ensure that clinical activities comply with applicable regulations and sponsor requirements.

This is a hybrid position based in Milan. The role requires at least 5 years of experience in clinical research within

Competenze

• At least 5 years of professional experience in clinical research within a CRO, pharmaceutical, biotech or medical device organization.
• Demonstrable experience in a Quality Assurance role specifically related to GCP-regulated clinical trials.
• Strong knowledge of ICH-GCP, EU Clinical Trials Regulation (EU) No. 536/2014 and applicable Italian and European clinical research requirements.
• Hands‑on experience in planning, conducting and documenting GCP audits.
• Experience in Quality Management Systems, SOP management, deviations, root cause analysis and CAPA processes.
• Excellent analytical, organizational and communication skills.
• Professional proficiency in written and spoken English and Italian.
• Bachelor’s or Master’s degree in life sciences, pharmacy, medicine or another relevant scientific discipline.

Mansioni

• Maintaining and improving the Quality Management System, including SOPs, policies, templates and quality records.
• Planning, conducting and reporting internal audits, vendor audits, investigator site audits and study-specific audits.
• Reviewing clinical trial documentation and processes from a quality and compliance perspective.
• Managing audit findings, deviations, root cause analyses and CAPAs.
• Supporting inspection readiness.
• Providing quality oversight throughout the clinical study lifecycle.
• Advising Clinical Operations and other functions on GCP compliance and quality-related matters.
• Contributing to GCP and quality training for internal staff.

Conoscenze

Quality Assurance

GCP experience

Audit planning

CAPA processes

Regulatory compliance

English & Italian proficiency

Formazione

Bachelor’s or Master’s degree in life sciences or related field

Descrizione del lavoro

Phidealive is seeking an experienced Quality Assurance professional with solid expertise in Good Clinical Practice (GCP) and clinical research. The successful candidate will support the oversight and continuous improvement of Phidealive’s Quality Management System and ensure that clinical activities comply with applicable regulations and sponsor requirements.

This is a hybrid position based in Milan. The role requires at least 5 years of experience in clinical research within