On-site GMP QC Compliance Specialist (12-month)

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

Benefits offered by this job

Onsite gym

Medical centre

Job summary

Sanofi Waterford is seeking a QC Compliance Specialist to represent QC for site-level processes and lead timely investigations of quality control events. You will drive CAPAs, track changes, and maintain robust QC documentation in line with the site QMS.

The role supports regulatory inspections, promotes continuous improvement, and ensures cGMP compliance, with a focus on quality and patient safety at our Waterford campus.

Qualifications

• Third Level qualification (degree in science or related discipline preferred).
• Experience in quality control within the pharmaceutical industry, including GMP/regulatory requirements.
• Experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow‑up.
• In‑depth understanding of pharmaceutical regulations, guidelines, and standards (FDA, EMA, ICH).
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions.
• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.
• Strong verbal and written communication skills to effectively convey compliance requirements and updates to stakeholders.

Responsibilities

• Representing QC for site-level processes led by QMS team.
• 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.
• Issuing and approving local quality control documentation aligned with the site QMS.
• Supporting regulatory inspections and audits.
• Leading continuous improvement initiatives in QC with the QC excellence team.
• Ensuring compliance to cGMP at all times.

Skills

Quality compliance

Regulatory understanding

Audits

Communication skills

Education

Degree in science

Job description

Sanofi Waterford is seeking a QC Compliance Specialist to represent QC for site-level processes and lead timely investigations of quality control events. You will drive CAPAs, track changes, and maintain robust QC documentation in line with the site QMS.

The role supports regulatory inspections, promotes continuous improvement, and ensures cGMP compliance, with a focus on quality and patient safety at our Waterford campus.