Senior Specialist, Quality

Merck; Leinster; Hybrid; EUR 70,000 - 97,000; Full time

Benefits offered by this job

Hybrid work model

Employee wellness program

Job summary

Merck in Dundalk, Ireland, seeks a Senior Specialist in Quality Assurance Operations to provide independent quality oversight across Drug Substance and Drug Product manufacturing. You will partner with Manufacturing, Quality Control, Engineering, Technical Operations, Supply Chain, and Quality Systems to ensure compliance and operational excellence.

This high-visibility role supports commercial manufacturing, technology transfer, investigations, and continuous improvement activities while

Qualifications

• Bachelor's degree in a scientific or engineering field.
• Minimum of 5 years in a GMP-regulated environment (pharma/biotech/biologics).
• Deep knowledge of GMP, Quality Systems, deviations, CAPA, and change control.

Responsibilities

• Provide quality oversight for Drug Substance and Drug Product manufacturing.
• 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.

Skills

GMP knowledge

Quality Systems

Investigations

Batch disposition

CAPA

Change control

Regulatory readiness

Cross-functional collaboration

Inspection readiness

Education

Bachelor's degree in Biotechnology, Microbiology, Pharmacy

Tools

Quality Management Systems (QMS)

Job description

Job Description

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.

Responsibilities

• 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 Details

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.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where