Quality Business Partner, Pre-clinical Research

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About the role

Our goal is for quality to be predictive, connected, flexible and seamlessly embedded in our daily operations, with a focus on anticipating and preventing problems.   For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029 .   Job Purpose   The Quality Business Partner (QBP) is the quality advocate for assigned areas of responsibility. This role will provide strategic, expert advice and consultation on R&D quality with impact across the area of responsibility. The role will educate aligned groups on Quality by Design, risk minimisation and mitigation, and partner to embed a strong quality culture.   The QBP will work closely with R&D pre-clinical research and therapy area research functions, to help the business understand potential impact of Quality risks, partner to embed Quality by Design principles into key processes and help R&D implement quality strategies according to the GSK Internal Control Framework.   Key Responsibilities:   • Serves as the Quality Business Partner for Research across R&D. • Defines the activities that need to be conducted to deliver quality strategies for R&D Research. • Collaborates with the Risk and Issue Management team within R&D Quality and Risk Management and the Research organisation to deliver quality activities that drive quality by design. • Shares key learnings to drive simplification and replicate best practices to drive quality into the business. • Works closely with business teams to provide expert quality information and support continuous improvement. • Evaluates, and/or reviews procedures and other activities in support of an integrated, cross functional QMS. • Fosters a commitment to quality in individuals and a culture of quality across GSK and GSK Third Parties. Facilitates effective communication and knowledge sharing across teams to promote a culture of quality. • Supports due diligence and Merger & Acquisition activities. • Works with R&D Data Analytics to define KPI, KQI and metrics needs for R&D Quality and Risk Management and stakeholders. • Ensures rapid communication of quality issues and risks, including potential misconduct, to appropriate leaders and colleagues. • Supports issues identification, reporting, root cause analysis and CAPA development. • Supports the investigations of potential serious and critical issues. • Participates in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT.   Why You? Basic Qualifications   • Bachelor’s degree or equivalent in scientific or quality-related field, or equivalent combination of education, training and experience. • Experience in drug development, regulatory compliance or quality management. • Expert knowledge of non-clinical research practices, GLP/GCP or Animal Welfare regulatory requirements. • Demonstrated experience of diverse stakeholder management with the ability to influence. • Broad working knowledge and expertise in principles and concepts of quality by design and risk management. • Expert working knowledge in continuous improvement with a background in the appropriate tools.   Preferred Qualifications   • Experience in developing quality strategies for emerging technologies e.g. organoids, AI/ML. • Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective. • Analytical mindset to develop effective quality strategies for dealing with current and future industr

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