Specialist, Quality Systems and Compliance

Job Description

An amazing opportunity has arisen for a Specialist, Quality Systems and Compliance at our R&D facility in Dunboyne. The purpose of this role is to work within and support the Global Development Quality Assurance team at our Research & Development Division facility in Dunboyne.

This role will provide support to Senior Quality Systems Specialists for Quality Management Systems and Quality Risk Management/Auditing, with a main focus on SAP master Data build and maintenance and supplier/vendor/material qualification activities. The QA Systems and Compliance Team will work closely with the Operations, Engineering, Validation, Supply Chain and AR&D Functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to our Company Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management and associated electronic systems.

What you will do:

Bring your energy, knowledge, and innovation to:

• Support Implementation and training for the site Quality Systems and ensure activities are in Compliance with the current Quality Manual Requirements.
• Support completion of Quality Systems activities e.g. related to Documentation Management, Auditing, Deviation Management, Change Control, Supplier Management and Quality Risk Management, per schedule.
• Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
• Create and maintain assigned SOPs.
• Participate in and support Internal/external Auditing activities in line with relevant guidance and industry best practice.
• Support gathering of site metrics.
• Ensure the escalation of compliance risks to management in a timely manner.
• Additional activities as assigned by the manager/supervisor.
• Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones.
• Support site QA Operations and QA Validation colleagues, as required.
• Participate in QMS Communities of Practice and support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture in our R&D facility.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor’s degree, or higher, in a Life Science discipline.
• Minimum of 3 years’ experience in an FDA/EMA regulated environment, ideally in Quality Assurance, Quality Control, Supply Chain or technical Operations within the Biological and/or pharmaceutical industry.
• Previous experience in QMS development and maintenance.
• Previous experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Previous experience in quality management systems such as Veeva, Delta-V, TrackWise, PAS-X etc. or similar.
• Strong knowledge in SAP usage.  
• Strong written and verbal communication skills.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals.

Required Skills:

Applied Engineering, Applied Engineering, Aseptic Manufacturing, Audit Management, Audits Compliance, Biopharmaceutical Industry, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Documentations, Driving Continuous Improvement, GMP Compliance, IS Audit, Production Management, Quality Assurance Tools, Quality Auditing, Quality Improvement, Quality Management, Quality Management System Improvement, Quality Management Systems (QMS), Quality Risk Assessment, Quality Standards, Regulatory Compliance, Root Cause Analysis (RCA), SAP Service Management {+ 3 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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 no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/7/2026

*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.