Quality Associate

2 weeks ago

Mriehel CBD Malta Orphalan Full time

1      Job overview:

The purpose of the role is to oversee clinical quality systems and provide assurance that trial designs, conduct, and reporting meet both regulatory requirements and company quality standards. This ensures data integrity, patient safety, and regulatory readiness for inspections and submissions.​

2      Responsibilities and 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.​

 

3      Requirements & Qualification:

  • 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.

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