QC Compliance Lead – GMP & Regulatory Readiness

Sanofi; Munster; On-site; EUR 42,000 - 56,000; Full time

Benefits offered by this job

Onsite gym

Medical Centre

Competitive benefits

Job summary

Sanofi Waterford is seeking a QC Compliance Specialist to join our on-site team in Waterford, Ireland. The role focuses on quality control processes, regulatory compliance, and active involvement in audits and inspections to ensure cGMP adherence.

You will represent QC within the QMS, drive investigations, CAPAs, change controls, and continuous improvement initiatives while supporting regulatory inspections and maintaining local QC documentation.

Qualifications

• Third Level qualification (degree in science or related discipline preferred).
• Experience in quality control within pharmaceutical industry and GMP/regulatory knowledge.
• Experience managing internal audits and external regulatory inspections.
• Understanding of pharmaceutical regulations, guidelines and standards (FDA/EMA/ICH).
• Ability to analyze compliance issues and develop effective solutions.
• Strong verbal and written communication to convey compliance requirements.

Responsibilities

• Representing QC for processes led by QMS team at site level.
• Investigating quality control events and discrepancies; implementing CAPAs.
• Managing follow-up and progress tracking of events, change control and CAPAs.
• Contributing to develop, implement, and maintain an effective QC compliance program.
• Issuance and approval of local QC documentation aligned with site QMS.
• Investigating timely quality events and implementing remediation actions.
• Providing support during regulatory inspections and audits.
• Leading continuous improvement initiatives in QC with QC excellence team.
• Ensuring compliance to cGMP at all times.

Skills

Quality control

GMP knowledge

Regulatory compliance

Audits & inspections

Root cause analysis

Stakeholder communication

Education

Science degree

Job description

Sanofi Waterford is seeking a QC Compliance Specialist to join our on-site team in Waterford, Ireland. The role focuses on quality control processes, regulatory compliance, and active involvement in audits and inspections to ensure cGMP adherence.

You will represent QC within the QMS, drive investigations, CAPAs, change controls, and continuous improvement initiatives while supporting regulatory inspections and maintaining local QC documentation.