Senior QA Operations Specialist - GMP Compliance

Msd Ireland; Dundalk; On-site; EUR 70,000 - 95,000; Full time

Job summary

MSD Ireland in Dundalk operates a state-of-the-art vaccines manufacturing facility focused on Drug Substance and Drug Product. The Senior Specialist in Quality Assurance Operations provides independent quality oversight, partnering with Manufacturing, QA, Engineering, and Supply Chain to support commercial manufacturing, tech transfer, investigations, and continuous improvement.

This role drives inspection readiness, supports audits, and champions a culture of quality and operational excellence

Qualifications

• Minimum 5 years in a regulated GMP environment (pharma/biotech/biologics).
• In-depth GMP knowledge, quality systems (deviations, CAPA, change control) and regulatory expectations.
• Proven ability to lead and support quality activities including investigations and batch disposition.

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 tech transfer and production teams for process validation and commercial manufacturing.
• Drive inspection readiness and support audits and regulatory inspections.
• Monitor quality metrics, identify trends, and drive continuous improvement initiatives.
• Provide GMP guidance across manufacturing and support functions.
• Support site and global quality projects and compliance programmes.

Skills

GMP experience

Quality Systems knowledge

Investigations & CAPA

Change control

Education

Bachelor's in scientific or engineering field (Biotech, Microbiology, Pharmacy, Life Sciences)

Job description

MSD Ireland in Dundalk operates a state-of-the-art vaccines manufacturing facility focused on Drug Substance and Drug Product. The Senior Specialist in Quality Assurance Operations provides independent quality oversight, partnering with Manufacturing, QA, Engineering, and Supply Chain to support commercial manufacturing, tech transfer, investigations, and continuous improvement.

This role drives inspection readiness, supports audits, and champions a culture of quality and operational excellence