PpbLocation /b: Belgium-Wavre, UK - County Durham, Barnard Castle, Upper Merion, USA - Pennsylvania, Upper Providence.br/bPosted Date /b: Mar .br/bNote /b: This role is advertised in certain locations, but applications from other locations may be considered on a case by case basis. /p h3Overview /h3 pThe Global Sterility Assurance Director at GlaxoSmithKline (GSK) is a pivotal role within the Strategic Product Quality staff. The Director brings critical expertise in sterility assurance across GSK’s internal and external commercial and RD vaccine and medicine drug substance and drug product manufacturing sites. The role ensures that both internal sterility assurance standards and external regulatory standards and guidance are comprehensively understood and effectively applied throughout the organization. /p h3Key Responsibilities /h3 ul liFacilitate interactions between Global sterility assurance and the CMO by establishing working relationships, including Service Level Agreements using Key Performance Indicators. /li liAct as the main point of contact for the CMO in supporting the implementation of GSK Sterility Assurance Strategy. /li liServe as the contact point for the CMO in establishing the annual Contamination Control Strategy (CCS) or Sterility Assurance Roadmap. /li liSupport the CMO in executing the annual CCS across sterility assurance domains, including training, troubleshooting, coaching/mentoring, and specific projects, and perform process confirmations on targeted topics. /li liPartner with the CMO on KPI analysis, trending, escalation, and gap assessment relative to standards such as Sterility Assurance GQPs, QMS, FDA Guidance, etc. /li liReview annual sterility assurance performance with the CMO and assist in preparing the next CCS. /li liEnsure availability of sterility assurance experts to support the CMO in specific domains according to annual CCS priorities. /li liAccountable for alignment in ways of working and standard works between the CMO and GSK on sterility assurance subjects. /li liAct as the sterility assurance quality generalist and single point of contact for issues or questions raised by the CMO. /li liLead or influence sterility assurance within external trade associations. /li liDevelop capability by supporting the development of sterility assurance capability across key business areas through training, coaching, and mentoring. /li /ul h3Basic Qualifications /h3 ul liBachelor’s degree in a scientific discipline. /li liSignificant experience in aseptic or bioburden control manufacturing environments (production, QA, validation) with demonstrated successful results, preferably in FDA-regulated environments. /li liIn-depth knowledge of regulations, guidance, best practices, and industry standards related to sterility assurance, including review of regulatory files. /li liStrong technical and quality skills in sterility assurance issues. /li liCoaching and mentoring capabilities for shop-floor training and education. /li liAbility to travel up to 30% internationally. /li /ul h3Preferred Qualifications /h3 ul liExcellent ability to influence, challenge, and educate leadership teams in sterility assurance to optimize vaccine operations. /li liPersonal credibility, confidence, and robustness to drive and influence senior colleagues. /li liAbility to make persuasive recommendations based on rational analysis. /li liAbility to network internally and externally and communicate to a wide base of partners. /li liStrong verbal and written English language skills. /li liStrong capability to work in a matrix organization both inside the Sterility Assurance team and outside in GSK networks. /li liResilience, capacity for adapting in different environments, and resistance to pressure. /li /ul pbClosing Date for Applications /b – 17th April 2026 EOD. Please read and apply before the closing date. If you have a disability and require assistance during the selection process, you may request specific assistance to facilitate a suitable arrangement. /p /p #J-18808-Ljbffr