Quality Assurance Manager

A leading biotech company in advanced clinical development stages is seeking a Clinical QA Manager for a key role with full responsibility for the Quality Management System (QMS) and all QA activities related to clinical trials in compliance with GCP standards.

Responsibilities

• Manage and maintain all QMS documentation and record
• Develop and update SOPs in accordance with evolving regulation
• Provide ongoing updates to the clinical team on regulatory changes and their impact
• Build and execute the annual audit plan
• Report directly to senior management on the status of the clinical quality system

Requirements

• 5+ years of experience in QA within clinical trial
• Proven and in-depth knowledge of GCP / GCLP standard
• Hands-on experience with electronic quality systems (eQMS, eLMS)
• Strong organizational skills and attention to detail, with the ability to manage multiple tasks simultaneously