CMC Quality Associate

Industry: Pharmaceutical / Life Sciences
Location: Malta
Basis: Full time
Remuneration: Salary + Benefits

Main Duties:

• Maintains quality oversight of the Quality Management System for clinical trials
• Plans, conduct, and report GCP audits of investigator sites, CROs, laboratories, and vendors. And internal systems
• Monitor and manage non-conformances, deviations, and CAPAs, ensuring timely resolution and trend analysis
• Review clinical study documentation (protocols, TMFs, monitoring reports) for compliance with SOPs and regulatory requirements
• Lead or support preparation for regulatory inspections (e.g., EMA, MHRA, FDA) and ensure readiness across all sites and teams
• Provide training on GCP, QMS procedures, and inspection readiness for cross-functional teams
• Contribute to risk management and quality metrics for ongoing oversight of clinical operations
• Collaborate closely with Clinical Operations, PV, and Data Management to ensure compliance throughout study execution

What skills do you need:

• 3+ years Quality Assurance in GxP-regulated environments
• Proficient in GxP regulations (GMP/GDP/GVP)
• Regulatory audit/inspection experience (EMA/MHRA/TGA) preferred
• QMS proficiency (CAPA, Deviations, Change Control, Audit)
• Experience of authoring SOPs, reports, protocols and other GxP documents
• Ability to research, analyze, and report independently on diverse topics
• Ability to work under pressure

Eligibility to work in the EU is a must

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