Quality Specialist

TL;DR

Quality Specialist (GCP/GxP): Manage SOPs and Sponsor quality documentation within the QMS, support quality systems and supplier qualification, and deliver Sponsor quality services with an accent on compliance reviews, CAPA/audit readiness, and KPI/KQI monitoring. Focus on GCP/GxP quality support, vendor/site/study audits, and maintaining ISO-certified quality systems to ensure study compliance and quality objectives.

Location: Italy

Company

hirify.global is an international CRO delivering Phase I–IV, non-interventional, and medical device studies with integrated clinical research services and quality assurance.

What you will do

• Manage SOPs, controlled documents, and Sponsor quality documentation within the QMS.
• Conduct compliance reviews of study documentation, systems, and training records; provide GCP/GxP quality support and escalate issues.
• Support CAPA management, audits, inspections, and audit readiness activities.
• Perform vendor, site, and study audits and support supplier qualification processes.
• Support quality services, risk assessments, and maintenance of GCP/GxP and ISO-certified quality systems.
• Coordinate quality training and monitor quality metrics (KPIs/KQIs) to drive continuous improvement and ensure timely completion of training and documentation.

Requirements

• Bachelor’s degree, preferably in Life Sciences or a related scientific field.
• Strong English communication skills.
• Proficiency in Microsoft Office applications.
• Excellent planning, organizational, and time-management skills.
• Strong interpersonal skills and ability to work collaboratively in a cross-functional team.

Culture & Benefits

• Competitive salary.
• Collaborative international environment.
• Opportunity to work on impactful clinical research projects.
• Professional growth and continuous learning.
• Dynamic role combining technology and healthcare innovation.

Hiring process

• Application review and evaluation of fit for quality/compliance responsibilities.
• Interviews to assess communication, documentation quality, and cross-functional collaboration.