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:

• Degree in life sciences, pharmacy, or a related scientific discipline
• Solid understanding of clinical development, study design, and trial operations
• Demonstrated experience in clinical QA, auditing, and inspection handling in the pharma, biotech, or CRO setting
• Strong knowledge of GCP, ICH E6(R3), and relevant health authority regulations
• Excellent communication and interpersonal skills for managing stakeholders and training staff

Eligibility to work in the EU is a must

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