Quality Manager

About the role

The Quality Manager will join the Quality & Compliance Department of TFS HealthScience, a global CRO, to lead and support the Quality Management System across clinical research projects. The role involves generating and revising QMS documents, driving risk assessments, CAPA plans, and supporting internal and external audits and inspections.

Key responsibilities

• Provide input and maintain content for the quality sections of RFI/RFP and quality assessments.
• Prepare, conduct and follow‑up on internal GxP audits and vendor audits.
• Support operational staff in preparing for customer and client audits, as well as regulatory inspections.
• Facilitate cross‑functional teams to create, update and keep current QMS documentation.
• Guide staff in completing risk assessments, root‑cause analyses and robust CAPA plans for all quality events.
• Assist with Computer System Validation (CSV) activities for company‑wide systems.

Required profile

• University degree or equivalent industry experience.
• Awareness of clinical trials and pharma industry with knowledge of GxP regulations.
• At least two years of experience in clinical research and CSV.
• Strong analytical mindset, attention to detail and proactive problem‑solving.
• Excellent written and oral communication skills in English.

Required skills

• Computer System Validation (CSV)
• GxP compliance
• Quality Management System (QMS) documentation