Job Description
Job DescriptionAn amazing opportunity has arisen in Dunboyne for a Senior Specialist, Quality Assurance in the Large Molecule Analytical Sciences Quality group. Large Molecule Analytical Sciences Quality is part of the Global Biologics Quality Organization and is responsible for technical, operational, and strategic quality oversight of a growing and fast-moving large molecule pipeline.The Senior Specialist Quality Assurance BCR that supports the Biological Critical Reagents (BCR) Hub, with guidance from the Associate Director of Quality Assurance, will lead Quality projects and support the QA strategy based on metrics and long-term strategy from the company.Bring energy, knowledge, innovation, and leadership to carry out the following:Responsible for BCR Quality oversight of BCR that support the vaccine modality.Performs documentation reviews for the disposition of BCRs, that includes but is not limited to: BCR transfer, qualification, re-evaluation, inventory, and shipping.Participates 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.Remain informed of current GMP requirements and industry trends in the large molecule, analytical, areas to applicable worldwide regulations and industry standards.Provide comments on proposed regulations and communicate impacts to client areas using a risk-based, phase-appropriate approach for decision making.Maintain an expert level of knowledge related to specialized area of technical expertise, specifically for analytical areas.Ensure departmental SOPs reflect departmental procedures and the current regulations.Responsibility for oversight of SOPs in supported areas and ensure periodic updates, as appropriate.Represent the department or area on project teams or committees establishing GMP, or quality standards, policies, or expectations within the Company.Apply technical / quality expertise to help teams remove obstacles, overcome technical challenges, and make impactful clinical disposition decisions.Collaborate with peer leaders in LMAS Quality Assurance to drive strategic initiatives and continuous improvement opportunities.Contribute to establishment and sustainability of a safety first, compliance always culture.What skills you will need:Bachelor’s degree in engineering, Biology, Chemistry, or related field.Strong scientific/technical expertise in the commercial space, coupled with the ability to collaborate with subject matter experts.Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within a commercial environment.Possess and apply large molecule drug substance technical knowledge (such as analytical method / development / transfer); demonstrated ability to share knowledge.Ability to support cross-functional analytical initiatives.Demonstrated experience with quality risk management.Strong cross-functional teamwork and collaboration skills.Demonstrated ability to communicate (oral and written) effectively with diverse individuals / groups.Experience in batch record review including operating in electronic batch records.Experience in start-up facilities or commercialization sites that support both clinical and commercial supply.Experience in a commercial Quality Control Lab performing analytical testing including potency-based methods.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.So, if you are ready to:Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today. #J-18808-Ljbffr