Quality Assurance GCP

PHIDEALIVE Srl; Milano; Hybrid; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

Phidealive S.r.l. is seeking an experienced Quality Assurance professional with strong GCP expertise to oversee the Quality Management System and ensure compliant clinical activities. The role involves audits, CAPAs, and training across the study lifecycle, with English and Italian proficiency in a hybrid Milan-based setting.

The candidate will collaborate with Clinical Operations to maintain inspection readiness and uphold regulatory standards within CRO/Pharma environments.

Qualifikationen

• Minimum 5 years in clinical research within CRO/pharma/biotech/medical devices.
• Demonstrated GCP quality assurance experience.
• Strong ICH-GCP and EU 536/2014 knowledge.
• Experience planning, conducting GCP audits.
• Ability to assess compliance risks and guide teams.
• Excellent English and Italian communication.

Aufgaben

• Maintain and improve the Quality Management System (QMS).
• Plan, conduct, and report internal, vendor, investigator site, and study audits.
• Review trial documentation for quality and compliance.
• Manage audit findings, deviations, CAPAs and root-cause analyses.
• Support inspection readiness.
• Provide quality oversight across the study lifecycle.
• Advise on GCP compliance to Clinical Operations.
• Contribute to GCP training for staff.

Kenntnisse

GCP compliance

Audit planning

QMS management

Regulatory knowledge

Bilingual EN-IT

Ausbildung

Life sciences degree

Jobbeschreibung

Phidealive S.r.l. is an independent Italian full-service Contract Research Organization (CRO) operating as aClinical Research Atelier.

Unlike large global CROs, we work through a selective, highly tailored model, combining scientific expertise, regulatory rigor and close operational involvement in every project. We partner with pharmaceutical and biotech companies, medical device developers and academic investigators to design and deliver clinical studies in Italy and internationally.

Our multidisciplinary team supports clinical development throughout the study lifecycle, from strategy and protocol design to regulatory activities, study start-up, project management, monitoring, data management, biostatistics and medical writing.

We focus on projects where quality, reliability and scientific value are essential to generating meaningful evidence and advancing healthcare solutions.

Role Description

Phidealive is seeking an experiencedQuality Assurance professional with solid and demonstrable expertise in Good Clinical Practice (GCP) and clinical research.

The successful candidate will support the oversight, maintenance and continuous improvement of Phidealive’s Quality Management System and ensure that clinical activities are conducted in compliance with applicable regulations, internal procedures and sponsor requirements.

Key responsibilities will include:

• 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 Corrective and Preventive Actions (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;

This is a hybrid position based in Milan.

Essential Qualifications

• At least 5 years of professional experience in clinical research within a CRO, pharmaceutical, biotech or medical device organization;
• Demonstrable experience in aQuality 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;
• Ability to independently assess compliance risks and provide practical, proportionate guidance to clinical project teams;
• 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.

Preferred Qualifications

• Previous experience in a CRO environment;
• Experience supporting inspection-readiness activities;
• Knowledge of ISO 14155 and quality requirements applicable to medical device clinical investigations;
• Experience delivering GCP and quality training.

Please note that this position requires specific, hands-on Quality Assurance experience in GCP-regulated clinical research. Candidates without direct experience in GCP Quality Assurance will not be considered.

If you are interested in joining an independent CRO where quality is an integral part of every project—not simply a final compliance check—we would be pleased to hear from you.