Job DescriptionFor our Human Health location Dunboyne, we are currently recruiting Senior Specialist Quality Assurance (Biological Critical Reagents)Welcome in our team Our GQ-LMAS (Global Quality Large Molecules Analytical Sciences) group is part of our Global Quality organization and serves as the technical authority for validated test methods crucial to product release and stability testing. With around 300 members across North America, Europe, and Asia, its mission is to ensure timely product release to patients by managing the lifecycle of analytical methods for large molecules. Key responsibilities include optimizing method performance, supplying critical reagents, providing strategic analytical guidance, improving program robustness, and supporting method modernization and validation processes. Within Global Quality, our Global Quality Assurance BCR team (7 FTE) oversees global Biological Critical Reagent programs for the Biologics and Vaccine sectors. To strengthen this team and establish a presence in Ireland, we are looking for a Senior Specialist Quality Assurance for our Dunboyne location.Purpose of the role Reporting to the Associate Director of Quality Assurance BCR in the US, you will play a crucial role in establishing standardized quality oversight for Biological Critical Reagents (BCR) that support vaccine development. In this newly created global position, you will collaborate with other Senior QA Specialists based in Dunboyne but also across other global GQ-LMAS sites across the world, to lead quality initiatives and enhance the QA strategy for BCRs, ensuring they effectively underpin the advancement of vaccine modalities.Main tasks Performing documentation reviews for the disposition of BCRs, that includes but is not limited to: BCR transfer, qualification, re-evaluation, inventory, and shipping.Managing the review and/or approval of analytical GMP documentation for applicable regulatory filings, clinical supply, development, and technology transfer.Participating in multi-disciplinary meetings to discuss content, progress, and quality of activities within the BCR Hubs.Quality representative for BCR hub in Supplier and customer interactions, Training/on-boarding QA of personnel, deviation management, change management, equipment control and disposition of BCRs.Remaining informed of current GMP requirements and industry trends in the large molecule, analytical, areas to applicable worldwide regulations and industry standards.Providing comments on proposed regulations and communicate impacts to client areas using a risk-based, phase-appropriate approach for decision making.Maintaining an expert level of knowledge related to specialized area of technical expertise, specifically for analytical areas.Ensuring departmental SOPs reflect departmental procedures and the current regulations.Responsibility for oversight of SOPs in supported areas and ensure periodic updates, as appropriate.Representing the department or area on project teams or committees establishing GMP, or quality standards, policies, or expectations within the Company.Applying technical / quality expertise to help teams remove obstacles, overcoming technical challenges, and making impactful clinical disposition decisions.Collaborating with peer leaders in LMAS Quality Assurance to drive strategic initiatives and continuous improvement opportunities.Contributing to establishment and sustainability of a safety first, compliance always culture.Your profile Bachelor’s degree in biology, chemistry, engineering or related field.A broad and relevant quality assurance background, having gained experience in overseeing analytical sciences in a pharmaceutical company.Strong compliance knowledge and understanding of Quality Management Systems, health authority regulations, and interpretation and application of GMPs within a commercial environment.Effective communication and collaboration abilities with an entrepreneurial spirit.Living within reasonable distance from Dunboyne. Who we areAs 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. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.Our facility in Dunboyne, Co. Meath 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. Our Dunboyne facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. Our Dunboyne facility serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them. Current Employees apply HERECurrent Contingent Workers apply HERESearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:01/1/2025*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.