Job Description

An exciting opportunity has arisen for an experienced Qualified Person to join our Quality department at our Biologics facility in Dunboyne, Co. Meath. 

Our facility in Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions.

What you will do:

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

Perform Qualified Person (QP) duties in certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.

Assure batch manufacturing and testing has been performed in accordance with cGMP and the relevant marketing authorization (MA) or clinical trial authorization, product specification file, legal obligations and/or technical agreement. Manage and/or escalate any potential CGMP and/or other concerns in a timely manner.​

Provide oversight of deviations (including approval of significant deviations) and laboratory investigations related to drug substance manufacture, testing and those that may present potential effect on product and /or material.

Confirm change requests with product impact which require expanded review (e.g., regulatory, stability, testing impact) have been appropriately reviewed, approved and technically closed.

Provide oversight ensuring all manufacturing, testing, and shipping processes remain in the validated state.

Review and approve the Annual Product Review for the drug substance and ensure that all variations, deviations, change controls and CAPA’s are included for the period under review.

Support supplier/material qualification and quality agreements review and approval as required.

Support customer and supplier complaint process as required.

Support Quality Risk Management processes as required.

Support Market Action Response Team as appropriate in batch / product recalls.

Ensure and promote compliance to regulatory requirements, evaluating site compliance against emerging regulatory trends and proactively engaging with global regulatory agencies when required.

Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.

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

Expert level of knowledge of relevant GMPs, regulations and current industry trends.

Communication, decision making, people influencing and project management skills.

Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues.

Knowledge, experience, and leadership style to lead the site through the planning, strategy build and execution to ensure RFT regulatory approval.

BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline.

Proven track record in delivering operational excellence.

EU QP Qualification and experience (at least 5 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.

Experience in the biotech industry is required with specific experience in audit readiness, regulatory agency engagement and ability to gain alignment on strategy with senior leadership.

As a company, we are committed to 'Inventing for Life' in all that we do. 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.

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:

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

Job Posting End Date:

01/5/2025

*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.

Requisition ID:R317637