Job Description

Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then.  The site plays a pivotal role in the manufacture of our Company’s biologics-based medicines, including immuno-oncology, and it has expanded our Company’s current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

The Quality Systems Specialist is responsible for maintaining and continuous improvement of the our quality management system throughout their knowledge and areas of expertise.

Ensure that objectives are effectively achieved, consistent with site requirements to ensure compliance, safety and reliable supply to our customers.

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

Provide quality support to the project and site, including training and guidance on the interpretation and implementation of site Guidelines Policies and regulatory requirements.
This position will include a combination of the responsibilities listed, such as: change control management and internal auditing.
Run-the-business support for critical quality systems to ensure continued sustainable compliance
Support management of the Global Change Management process at the site as well as drive best practices.
Ensure the health & well being of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs
Serve as support for metrics management for site change control and internal auditing systems.
Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a routine basis and responsible for the completion of annual trending at Site.
Support for management of Site Manufacturing licence(s) compliance, and associated activities.
Support Regulatory and Divisional Audit Inspections at the site as required.
Support for management of recalls, as required.
Comply with site Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Build a Quality culture that delivers unconstrained supply, Right First Time to our patients

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

Bachelor or Master’s degree in Biological Sciences or equivalent.
5 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations.
Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and respective regulations.
Experience with new product introductions and/or process qualification/technology transfer.
Desire to continuously learn, improve and develop and motivated to be an inspiring member of a high performing team
Excellent communicator, decisive decision maker, willingness to support the team and proven ability to deliver excellence.

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.

Required Skills:

Change Controls, Continuous Improvement Techniques, Deviations, Good Manufacturing Practices (GMP), Quality Auditing, Quality Management, Quality Management Systems (QMS), Stakeholder Relationship Management

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:

05/30/2026

*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.

Quality Systems Specialist

Benefits

Job Description