Senior QC Analyst - Gene Therapy & GMP Analytics

MeiraGTx; Ireland; On-site; EUR 65,000 - 90,000; Full time

Job summary

MeiraGTx is seeking a QC Specialist to ensure GMP-compliant QC activities supporting plasmid and gene therapy product manufacture and release. You will lead investigations, support method transfer, and oversee in-process testing while ensuring data integrity and regulatory compliance.

The role requires strong expertise in QC analytics, leadership, and cross-functional collaboration, with extensive experience in GMP environments and regulatory expectations.

Qualifications

• Degree in Human Health or Sciences or equivalent relevant work experience.
• Minimum 8 years’ experience in Pharmaceutical/Biotech industry.
• Strong GMP, GDP and Data Integrity knowledge.
• Experience with gene therapy/ biologics batch release and stability studies.
• Excellent collaboration, communication and problem-solving skills.

Responsibilities

• Ensure GMP, Data Integrity and GDP compliance for QC activities.
• Lead investigations of QC issues and CAPAs when needed.
• Support technical transfer and method validation in QC labs.
• Develop and qualify analytical methods (HPLC, CE, PCR, cell culture assays).
• Provide SME input during inspections and audits.
• Maintain data integrity and regulatory compliance across QC processes.

Skills

Analytical

Leadership

Problem solving

Planning/Organizing

Oral communication

Written communication

Quality management

Education

Degree in Human Health or Sciences

Job description

MeiraGTx is seeking a QC Specialist to ensure GMP-compliant QC activities supporting plasmid and gene therapy product manufacture and release. You will lead investigations, support method transfer, and oversee in-process testing while ensuring data integrity and regulatory compliance.

The role requires strong expertise in QC analytics, leadership, and cross-functional collaboration, with extensive experience in GMP environments and regulatory expectations.