Site Name: UK London New Oxford Street, Belgium Wavre, France Evreux, France Mayenne, GSK Aranda de Duero, Burgos, Mississauga Milverton Drive, UK County Durham Barnard Castle, UK Hertfordshire Ware, Upper Merion, USA Maryland Rockville, USA North Carolina Durham, USA North Carolina Zebulon Posted Date: Jan 8 2025 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in office work. External Quality Regulatory Compliance Lead Do you want to be a key asset for business transformation? Then this may be the role for you. As the External Quality Regulatory Compliance Lead you get the opportunity to own and contribute to transformation projects for processes related quality and regulatory. This a global role providing a lot of exposure, interfacing with multiple stakeholders and quality leadership team, which is great for visibility and future development. Job Purpose The EQ Regulatory Compliance Lead role is responsible for key systems and processes for change control, regulatory conformance and compliance within External Quality. The role also develops, coordinates and provides an expert input into regulatory strategies and compliance topics for the manufacture and registration of drug products and drug substances managed in external quality. In this role you will... Be responsible for advising on regulatory compliance and conformance by the interpretation of registered details such as Preliminary Regulatory Advice as part of the change control assessment process, corporate standards, pharmacopoeial requirements, regulatory authority directives and commitments. Provide consultancy on regulatory compliance and conformance topics. Follow up on intelligence on new legislation and regulatory/pharmacopoeial requirements and provide an expert interpretation of impact to the business, and actively communicate this to the relevant stakeholders. Own, maintain and improve the following processes and ensure input and alignment with the associated enterprise QMS documents: Quality change control process and linkage with Regulatory change control processes and systems (such as Veeva), the quality regulatory intelligence process, pharmacopoeial compliance process and associated tools within External Quality. Ensure these processes and tools are in use and manage the performance through metrics. Deliver training as required. Drive simplification and harmonisation across External Quality. Act as interface between Central Regulatory Compliance and GRA and External Manufacturing team, in order to drive implementation of regulatory conformance and compliance r