Senior GMP QA Specialist

Role Overview

The Senior Quality Assurance Specialist (12-month FTC) will be responsible for ensuring GMP compliance during the manufacturing and testing of gene-modified cell therapies in clinical stages. This includes managing internal quality systems, overseeing outsourced GMP activities, and maintaining regulatory standards.

Key Responsibilities

• Ensure GMP compliance in manufacturing and testing of gene-modified cell therapy products.
• Implement and improve internal quality systems, focusing on risk management, training, and continuous improvement.
• Review and approve critical quality documentation in line with regulatory requirements.
• Conduct risk assessments on deviations, changes, and other GMP-related events.
• Manage vendor qualification, ensuring compliance with GMP for outsourced activities.
• Collaborate with internal teams (R&D, clinical operations) to provide quality support.
• Lead or support cross-functional quality projects and meetings.
• Oversee procurement, testing, and compliance of raw materials in line with regulatory standards.

Experience & Skills

• Strong background in pharmaceutical quality assurance, particularly in biologics or advanced therapies.
• Deep understanding of GMP, regulatory requirements, and clinical-stage product development.
• Excellent communication skills and the ability to manage complex documentation.
• Proficient in eQMS and risk management tools.

Education

• Degree in biological science, chemistry, or a related discipline.