Tech Stack

Description

You will be responsible for batch certification and release of clinical and commercial medicinal products in compliance with EU regulations. You will conduct supplier audits, lead inspection readiness activities, and monitor regulatory changes to ensure ongoing compliance. Your work is critical to delivering life-changing therapies to patients.

Requirements

• In-depth knowledge of EU and UK GMP regulatory compliance
• Qualified Person (QP) status as per Directive 2001/83/EC
• Experience in supplier and contract service provider audits
• Ability to work across multiple time zones
• Strong communication and team collaboration skills

Responsibilities

• Certify and release batches of medicinal products in compliance with EU GMP and regulatory requirements
• Oversee quality and compliance of outsourced manufacturing and testing at European CDMOs
• Conduct audits of suppliers and contract service providers
• Establish and maintain infrastructure for HPRA and EU Competent Authority inspections
• Participate in annual Quality Management Review and Annual Product Reviews