QA Operations Leader — GMP & Investigations

MSD; Dundalk; Hybrid; EUR 70,000 - 110,000; Full time

Job summary

MSD is seeking a Senior Specialist in Quality Assurance Operations at our Dundalk vaccines facility. You will provide independent quality oversight across Drug Substance and Drug Product manufacturing, reviewing GMP documentation and supporting batch disposition, investigations, CAPA, and change controls.

You will partner with manufacturing, QC, Engineering, and Supply Chain to support technology transfer, process validation, and continuous improvement while ensuring inspection readiness and

Qualifications

• Bachelor's degree in a scientific or engineering field.
• Minimum 5 years of experience in a regulated GMP environment.
• Knowledge of GMP requirements, Quality Systems, and regulatory expectations.
• Ability to lead investigations, batch disposition, and inspection readiness.

Responsibilities

• Provide quality oversight for Drug Substance and Drug Product manufacturing operations.
• Review and approve GMP documentation, batch records, protocols, reports, and manufacturing records.
• Support batch disposition activities and quality decision-making processes.
• Lead investigations, deviations, CAPA, change controls, and risk assessments.
• Partner with manufacturing and technical teams for technology transfer and process validation.
• Drive inspection readiness and support audits and regulatory inspections.
• Monitor quality performance metrics and drive continuous improvement.
• Provide GMP guidance across manufacturing and support functions.

Skills

GMP knowledge

QA operations

Deviations handling

CAPA

Change control

Investigations

Tech transfer

Process validation

Inspection readiness

Quality systems

Education

Bachelor's degree in Life Sciences

Tools

QMS

Job description

MSD is seeking a Senior Specialist in Quality Assurance Operations at our Dundalk vaccines facility. You will provide independent quality oversight across Drug Substance and Drug Product manufacturing, reviewing GMP documentation and supporting batch disposition, investigations, CAPA, and change controls.

You will partner with manufacturing, QC, Engineering, and Supply Chain to support technology transfer, process validation, and continuous improvement while ensuring inspection readiness and