Site Name: Poznan Grunwaldzka Posted Date: Feb 5 2025 This role supports the Quality relationship with assigned External CMOs / Suppliers in External Supply specific region to ensure GSK’s product quality, compliance, and reputation is protected. Additionally this role ensures the appropriate level of oversight with regards to CMO GMP activities in accordance with quality agreements by establishing and maintaining an effective working relationship with key contacts at the assigned CMOs / Supplier(s). Key Responsibilities: Recommend and support implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external CMOs/suppliers are met. Support collection, monitoring and analysis of quality performance indicators of the external CMOs/Suppliers using quality standards and tools in place to identify/escalate emerging/developing trends and where appropriate use risk management tools to escalate and track significant risks requiring resolution. As required reporting to Quality Council, Local Incident Committee & Product incident Review Committee (LIC, PIRC) or other corporate governance processes, and as required ensure appropriate plans in place such as GEMBA in order to assess the Supplier on the shop floor. Partner with External Suppliers and ES Procurement, Quality, Technical and Supply (PQTS+) to ensure that potential quality and compliance issues are identified, communicated and promptly resolved in order to maintain a secure source of supply of quality product. Provide specific GMP training for contractors, where deemed necessary. Work with External Suppliers to establish effective CAPAs, in response to GSK audit observations and ensure the Suppliers manage these to acceptable closure. Ensure timely communication of Quality Alert issues. Coordinate and track any continuous improvement /Quality Plans deemed necessary. Build & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreements as applicable. Support Product Incident Alerts, Stock Recoveries and Product Recalls as directed. Basic Qualifications: 1+ year experience in various Technical, Regulatory or Quality Assurance roles with an understanding of quality systems and quality control processes Developing knowledge of GMP's, FDA, EU and other regulatory agency requirements with an ability to apply to quality and compliance Developing knowledge of quality system principles and practical applications. Developing knowledge and ability to apply quality and risk management principles and tools and demonstrated problem solving skills. Demonstrated ability to make grade level decisions based on facts and data and application of risk management principles Experience with work related travel Developing presentation skills Developing influencing and negotiating skills Capable of working independently and as a member of cross functional teams #LI-GSK G9 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. GSK is an Equal Opportunity/Affirmative Action Employer. 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