Senior Clinical Quality Associate

Senior Clinical Quality Associate – GCP / Medical Devices

Location: Belgium

Contract: Initial 12 months, with potential for rolling 12-month extensions

We are looking for a Senior Clinical Quality Associate to support clinical study teams with GCP compliance and medical device regulations. The role covers study document review, CAPA management, audit preparation and inspection readiness across global clinical projects.

Responsibilities

• Review clinical study documents against applicable regulations, standards and internal procedures.
• Advise study teams on GCP and clinical quality requirements.
• Investigate quality issues, prepare CAPA plans and coordinate their resolution across teams.
• Support internal and external audits, including responses to findings.
• Help project teams prepare for regulatory authority inspections.
• Identify opportunities to improve clinical quality processes.

Requirements

• At least four years of relevant experience, with a strong understanding of clinical quality or GCP compliance.
• Knowledge of medical device clinical research requirements, including ISO 14155 and relevant US regulations.
• Experience preparing CAPA documentation and resolving quality issues.
• Strong written communication, planning and problem-solving skills.
• Ability to make sound decisions and work independently.
• A relevant degree or equivalent professional experience.

GCP audit experience and a background in medical device clinical quality would be particularly valuable.

Interested? Apply through LinkedIn with your CV.