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Sr. Spclst, Quality Assurance

at MSD in Dunboyne, IE

Work Type: On Premise | Employment Type: Full Time

Experience Level: Senior Level | Posted Date: 14/04/2025

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Description

Job Description

The purpose of this Sr. Spclst, Quality Assurance role is to work within and support the Global Development Quality Assurance team at the Research & Development Division facility in Dunboyne.  This role will provide support to the Associate Director QA Systems and Compliance by leading the deployment and maintenance of the QMS, and associated Systems, leading Quality Council required meetings at the Dunboyne facility, and supporting colleagues with Quality Risk Management & Auditing. The role will also act as a mentor and support for more junior team members across QA.

The QA Systems and Compliance Team with 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 the Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management and associated electronic systems.

Bring energy, knowledge, innovation to carry out the following:

• Manages and oversees the site QMS.
• Ensures compliance with QMS requirements and procedures.
• Initiates and maintains Quality related metrics related to QMS, ensuring effective 
  communication and follow up of same.
• Ensures a documentation system is in place and is compliant with requirements.
• Reviews and approves documents as defined by QMS requirements.
• Ensures there is a change management system to assess the impact of changes on 
  product, validated process, test methods, specifications, regulatory filing and GMP documents.
• Ensures there is a Deviation Management system to document and investigate unplanned events and effective CAPA for same.
• Ensures there is a process and system for management of approved suppliers at site.
• Co-ordinates the Site Quality Council activities.
• Implements any changes to the Quality Management System at the site.
• Provides quality support to the project and site, including training and guidance on 
  the interpretation and implementation of Guidelines / Policies and regulatory requirements.
• Represents the site’s Quality Management System during GMP inspections.
• Leads training of staff to assure appropriate level of compliance across all areas.
• Supports maintenance and continuous improvement of quality management systems and associated documentation.
• Participates in Communities of Practice for Quality Systems owned QMS topics.
• Participates in walkthrough audits and Permanent Inspection Readiness
• Develops, maintains & reports relevant metrics to site and above site functions.
• Supports colleagues for Quality Risk Management, Internal and External Auditing and Permanent Inspection Readiness.
• Works collaboratively to drive a safe and compliant culture in.
• Ensures the escalation of compliance risks to management in a timely manner. 
• Additional activities as assigned by the manager/supervisor

What skills you will need:

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

• Degree qualification (Science/Quality/Technical).
• Minimum 6 years experience, ideally in Quality Control / Manufacturing / Technical Operations and Quality Assurance
• Thorough understanding of major Health Authority Guidelines and Regulations.
• Working knowledge of Quality Control, Manufacturing and Supplier processes to apply to performing internal Audits.
• Experience in Health Authority Inspections
• Ability to think logically and be proactive under pressure or when the path forward is uncertain.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Flexible and self-motivated.

This role is a hybrid role, with a minimum requirement for 3 days per week onsite

In Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from Ireland to the world.

Our Commitment to Ireland:

We are one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of the company’s top products, helping save and enhance lives in over 140 countries around the world.

The latest addition to the Ireland family is Dunboyne which joined our network in September 2020. Our Dunboyne site is the company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines as the newest addition to the company network. The cutting-edge innovation and collaboration between Dunboyne’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

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 diverse, 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, please apply today.

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:

04/28/2025

*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.