Senior Quality Assurance Systems Specialist

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Senior Quality Assurance Systems Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Groningen office, until the end of December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

In this position you will be responsible for managing and maintaining key Quality Systems with primary ownership of the Training System and coordination of external audits. This role ensures compliance with regulatory requirements, supports continuous improvement, and drives inspection readiness.

 

Main Job Tasks and Responsibilities:

External Audit Coordination

• Serve as the primary coordinator for external audits (e.g., regulatory authorities, notified bodies, customers).
• Plan, schedule, and manage audit activities across departments.
• Act as the main point of contact for auditors during inspections.
• Ensure timely preparation of audit materials (SMEs, documentation, facility readiness).

Lead audit response activities, including:

• Coordination of responses to audit observations
• Tracking and closure of CAPAs (Corrective and Preventive Actions)

Ownership of Training System

• Own and manage the site GxP Training System.