Site Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, UK – London – New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham Posted Date: Nov 6 2024 Director, Quality Business Partner – Third Party This role will preferably be based at GSK Upper Providence, PA, Cambridge, MA or Durham, NC or but can also be based at other strategic locations on a case-by case basis. This is a truly exciting position as the Quality Business Partner will be the quality advocate and change agent for their given area of responsibility. The role holder will provide strategic, expert advice and consultation on the quality strategy with impact across the regulatory and quality area of responsibility (in this case Third Parties). The role will drive quality into business by educating assigned groups on Quality by Design, regulatory compliance, risk minimization and mitigation. The QBP will help the business and Third Parties understand potential impact of Quality risks and alternatives to best address the risk. They will help R&D to design and implement strategies for quality and getting right first time as well as oversight according to the GSK Internal Control Framework. In this role you will: Serves as the Quality Business Partner for assigned GSK R&D functions, programs and/or Third Parties. Works closely with business to provide expert quality information, manage identified issues and support continuous improvement. Provides matrix management and leadership to cross-functional teams. Collaborates with the Audit, Inspection, Risk and Issue Management team within R&D Quality and Risk Management on all internal quality audits, regulatory agency inspections, risk assessments, issue and CAPA activities. Leads inspection readiness activities and supports regulatory inspections. Supports issues identification, reporting, root cause analysis and CAPA development. Evaluates, and/or reviews standard operating procedures and other activities in support of an integrated, cross functional Quality Management System. Influences senior leaders to foster a commitment to quality and a culture of quality across GSK and GSK Third Parties Why You Basic Qualifications: Degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge Experience in drug development, regulatory compliance or quality management. Experience in clinical, medical, pharmacovigilance or regulatory quality. Expert knowledge of GLP, GCP, GVP and regulatory requirements Experience interfacing and influencing senior Global Leadership team stakeholders Strong leadership skills Prior experience in leading cross functional project and/or matrix teams to an aligned strategy Preferred qualifications and skills: BA/BS or Masters Degree Broad working knowledge/expertise in principles and concepts of quality by design, quality briefs and risk management Expert working knowledge in continuous improvement with a background in the appropriate tools. 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 industry trends. Ability to adapt to changing direction and needs of the business; can directly apply this knowledge into daily tasks and assignments. Effective communication/negotiation skills and customer management skills #LI-GSK Please take a copy of the Job Description, as this will not be available post closure of the advert. During the course of your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. 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