Site Name: UK - London, Belgium-Wavre, Singapore - Tuas, UK - United Kingdom, USA - Pennsylvania - Upper Providence, Ware Posted Date: Aug 30 2024 Job purpose: As the Small Molecule R&D Quality Director, you perform the quality assurance activities and quality oversight of the GMP functions performed within Small Molecule R&D, e ssentially related to the manufacturing of clinical material. Your responsibilities: As the Small Molecule R&D Quality Director, you Develop and implement strategy, policy and group objectives that build competency in operational excellence in quality assurance of clinical products. Are accountable for building continuous improvement into the processes and ways of working to optimize end to end quality and right first time. Interact with regulators and/or industry experts to represent GSK interests. Are responsible for leading the team in a dynamic matrixed environment by setting standards, objectives and measurements to...

Site Name: Upper Merion, Belgium-Wavre, USA - Pennsylvania - Upper Providence Posted Date: Aug 1 2024 The Reference Material and Reagents Director is accountable for ensuring critical reagents and analytical standards are available for the GSK network. They must be of the required regulatory standards and coordination and supply to GSK sites, CMO and LOC to support end to end supply chain of products to the patient. The role will ensure long term availability and lifecycle management of reference materials for existing and new GSK products. You will ensure outsource partners are maintained, ensuring a priority service to GSK is maintained and that bulk materials are effectively supplied to the outsource partner in a timely manner, along with supporting information to maintain a secure supply of reference materials. Also, ensure GSK customer changes, risks and issues are managed and dealt with associated with the service provided from the outsource partner. This role will...

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Sep 12 2024 As a Regulatory Compliance Specialist you have the responsibility and accountability to support the Regulatory Compliance programs at site. The Regulatory Compliance Specialist supports the Regulatory Compliance Lead to ensure compliance objectives are met with respect to regulatory submission processes, change and deviation management, and routinely evaluates and communicates Regulatory Intelligence. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Responsible for reviewing all proposed technical changes via Change Control System, and providing guidance to the impact on regulatory submissions, and using this information to assist change owners in the assessment of scope for the change. Responsible for supporting Change Owners with RIS (Regulatory Implementation Strategy) Meetings for Change Controls with...

Site Name: Upper Merion, Belgium-Wavre, UK - Hertfordshire - Stevenage, UK - London, USA - Pennsylvania - Philadelphia Posted Date: Jun 24 2024 The Reference Material and Reagents Director is accountable for ensuring critical reagents and analytical standards are available for the GSK network. They must be of the required regulatory standards and coordination and supply to GSK sites, CMO and LOC to support end to end supply chain of products to the patient. The role will ensure long term availability and lifecycle management of reference materials for existing and new GSK products. You will ensure outsource partners are maintained, ensuring a priority service to GSK is maintained and that bulk materials are effectively supplied to the outsource partner in a timely manner, along with supporting information to maintain a secure supply of reference materials. Also, ensure GSK customer changes, risks and issues are managed and dealt with associated with the service provided from...