Senior Specialist, Quality

MSD Ireland; Dundalk; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GMP experience

Quality Systems knowledge

Investigations & CAPA

Change control

Formation

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

Description du poste

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.

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.

Required

What Skills You Will Need

• 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

Secondary Language(s) Job Description

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.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

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.

Please feel free to speak to us about what flexibility means to you during your application.

So, If You Are Ready To

Invent solutions to meet unmet healthcare needs,

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

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R414976