QC Compliance Specialist — cGMP & Regulatory Audits

Sanofi; Waterford; On-site; EUR 48,000 - 64,000; Full time

Job summary

Sanofi Waterford is seeking a QC Compliance Specialist on a fixed term contract to oversee quality governance for QC processes on-site. You will ensure timely investigation and remediation of QC events, lead CAPA actions, and support regulatory inspections.

The role requires a science degree, GMP/regulatory experience, and strong communication with stakeholders. This position offers a challenging environment within a world-class biopharma campus.

Qualifications

• Degree in science or related discipline.
• Experience in quality control within pharma, including GMP knowledge.
• Experience managing internal audits and regulatory inspections.
• Understanding pharmaceutical regulations (FDA, EMA, ICH).
• Strong verbal and written communication to convey compliance requirements.

Responsibilities

• Represent QC for processes led by QMS at site level.
• Investigate and resolve quality control events and discrepancies in a timely manner.
• Implement remediation actions from findings and CAPAs.
• Support regulatory inspections and audits and drive continuous QC improvements.

Skills

Quality control

Regulatory compliance

GMP knowledge

Audits

Communication

Education

Science degree

Third-level qualification

Job description

Sanofi Waterford is seeking a QC Compliance Specialist on a fixed term contract to oversee quality governance for QC processes on-site. You will ensure timely investigation and remediation of QC events, lead CAPA actions, and support regulatory inspections.

The role requires a science degree, GMP/regulatory experience, and strong communication with stakeholders. This position offers a challenging environment within a world-class biopharma campus.