Senior QC Compliance Lead, GMP & Quality Assurance

MeiraGTx; Ireland; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

MeiraGTx is seeking a QC Senior Compliance Specialist to ensure GMP-compliant activities within QC supporting gene therapy product manufacture. You will review and approve QC documentation to support batch release and drive KPI reporting.

You will coordinate stability records, support investigations, and work with QC teams to close CAPAs, deviations, and change controls within timelines. Strong attention to detail and data integrity are essential.

Qualifications

• Minimum 4 years experience working in QC or QA GMP environment.
• Experience of quality documentation review and approval (QC/Manufacturing batch records).
• Proficiency in Microsoft Office software (Word, Excel and PowerPoint).

Responsabilités

• GMP Compliance activities in QC.
• Management of audit schedule.
• Quality record KPI tracking and reporting.

Formation

Degree in a scientific discipline

Outils

MS Office

Description du poste

MeiraGTx is seeking a QC Senior Compliance Specialist to ensure GMP-compliant activities within QC supporting gene therapy product manufacture. You will review and approve QC documentation to support batch release and drive KPI reporting.

You will coordinate stability records, support investigations, and work with QC teams to close CAPAs, deviations, and change controls within timelines. Strong attention to detail and data integrity are essential.