Senior Specialist, Quality

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

Job Description About the Role and Site

Join a state-of-the-art vaccines manufacturing facility in Dundalk and play a critical role in ensuring the highest standards of quality, compliance, and operational excellence across both Drug Substance and Drug Product manufacturing operations. As a Senior Specialist within Quality Assurance Operations, you will provide independent quality oversight, partnering closely with Manufacturing, Quality Control, Engineering, Technical Operations, Supply Chain, and Quality Systems teams. This highly visible role supports commercial manufacturing, technology transfer, investigations, and continuous improvement activities while helping to maintain a culture of quality and inspection readiness. This is an excellent opportunity for a quality professional looking to broaden their impact in a fast-paced manufacturing environment while working across multiple operational functions. Bring energy, knowledge, and innovation to carry out the following: Provide quality oversight and support 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 and support investigations, deviations, corrective and preventive actions, change controls, and risk assessments. Partner with manufacturing and technical teams to support technology transfer, process validation, and commercial manufacturing activities. Drive inspection readiness and support internal audits and regulatory inspections. Monitor quality performance metrics, identify trends, and implement continuous improvement initiatives. Provide GMP guidance and quality expertise across manufacturing and support functions. Support site and global quality projects, change initiatives, and compliance programmes. Champion a culture of quality, compliance, accountability, and operational excellence.

What Skills You Will Need

Required Bachelor's degree in a scientific or engineering field (such as Biotechnology, Microbiology, Pharmacy, or a related Life Sciences discipline). Minimum of 5 years of relevant experience in a regulated Good Manufacturing Practice (GMP) environment, such as pharmaceutical, biotechnology, or biologics manufacturing. In-depth knowledge of GMP requirements, Quality Systems (e.g., deviations, CAPA, change control), and global regulatory expectations. Proven ability to lead and support quality activities, including investigations, batch disposition, and inspection readiness programmes. Preferred Strong collaborative and influencing skills, with the ability to partner effectively with cross-functional teams and stakeholders. Proven experience with Quality Management Systems, including participation in the implementation and deployment of QMS. Demonstrated leadership capabilities with excellent problem-solving, risk-based decision-making, and oral and written communication skills. Experience supporting technology transfers, process validation, and continuous improvement initiatives. Expertise in bioprocessing, aseptic manufacturing, or commercial manufacturing support. Passion for fostering a culture of quality, compliance, and operational excellence.

Additional location(s) Compensation Information: Required Skills: cGMP Regulations, Change Management, Deviation Management, Pharmaceutical Quality Assurance, Quality Management Standards, Quality Standards, Risk Management, Strategic Planning

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing inclusive, talented, and committed people together.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date: 11/7/2026