Site Name: UK - Hertfordshire - Stevenage, GSK HQ Posted Date: Sep 10 2024 Job Purpose The purpose of the role is to be the quality advocate for their given area of responsibility. The role provides strategic, expert advice and consultation on R&D quality with impact across the Good Practices. The role will educate assigned groups on Quality by Design, GxP risk minimization and mitigation; and will help the business and GSK’s Third Party partners understand potential impact of Quality risks and alternatives to best address the risk. Key Responsibilities Serve as the quality business partner for assigned GSK R&D functions, programs and/or Third Parties supporting Health Care technologies, Invitro devices (IVD’s) and lab methods Work closely with business and/or Third Party teams to provide expert quality information, manage identified issues and support continuous improvement particularly in scope of Health Care Technologies, IVDR and clinical lab regulations. Collaborates with the Audit, Inspection, Risk and Issue Management teams within R&D Quality and Risk Management function on all internal quality audits, regulatory agency inspections, risk assessments, issue and CAPA activities Supports evaluation of R&D to emerging Health Care Technologies and IVD regulations in our portfolio Supports issue identification, reporting, root cause analysis and CAPA development Evaluates, and/or reviews standard operating procedures and performs other activities in support of an integrated, cross functional QMS Provides matrix management and leadership to cross-functional teams Fosters a commitment to quality in individuals and a culture of quality across GKS and GSK Third Parties Responsible for quality consultation for the assigned function, program and/or Third Party Defines, implements and monitors the quality narrative/quality brief and reports any critical risk Defines the activities that need to be conducted to deliver the quality strategy for the assigned function, program and/or Third Party Supports due diligence and Merger & Acquisition activities Ensures rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues. Supports the investigations of potential serious breaches and critical issues Participate in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT Shares key learning’s to drive simplification and replicate best practices to drive quality into the business Minimum Requirements Beachelors Degree in a Scientific Discipline Experience in invitro device regulations Experience in healthcare technologies and devices from a quality and regulatory perspective Preferred Qualifications Minimum 8 years in drug development, regulatory compliance or quality management Minimum 3 years in clinical, medical, pharmacovigilance or regulatory quality Demonstrated knowledge of GLP, GCP, GVP and regulatory requirements 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. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. 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