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.
Required Skills: cGMP Regulations, Change Management, Deviation Management, Pharmaceutical Quality Assurance, Quality Management Standards, Quality Standards, Risk Management, Strategic Planning
Additional Information
•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
