Job Description
For our Human Health location Dunboyne, we are currently recruiting Senior Specialist Quality Assurance (Biological Critical Reagents).
Welcome to 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 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 are
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. 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 Dunboyne, but that the facility belongs to and is shaped by them.
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