Site Name: UK - County Durham - Barnard Castle Posted Date: Dec 7 2022 We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together Reference Material Analytical Lead You will ensure all analytical aspects of the outsource model are managed effectively to maintain a consistent supply of reference materials to the business. The role will report to the RM Outsource Manager. The expectation is a much broader matrix role interacting with the outsource partner in Germany, the GSK network (R&D and GSC) and the wider GQC-SM (Global Quality Control – Small Molecules) team In this role you will Prepare detailed knowledge transfer documents for the Outsource partner, providing certification requirements, analytical methodology, acceptance criteria & details of stability testing requirements. Source internal GSK & third-party methodology, ensuring it is appropriate for the end use of the reference material and compliant with registered detail. Oversee stability testing programmes to ensure data are available, as required to support certified values throughout life of reference materials. Coordinate collaborative testing by sites, as required Have management oversight of Laboratory Investigations at Outsource partner drawing on experience and knowledge from within the GSK business to resolve issues Lead internal deviations and support impact assessments of atypical and OOS data with the customer sites Lead Analytical improvement projects for reference materials: Method equivalence, method improvements, method transfer for NCEs Review of GMP relevant documents (e.g., QMS, GQPs, SOPs & ATSs) to ensure alignment with GSK expectations Review of quality alerts and bulletins, for analytical impact and ensuring implementation of CAPA Respond to customer queries, provide audit support and provide data as requested. Support outsource partner with order management, to reduce the risk of stock outs Conduct information and data searches using GSK systems such as VQD, VQMS, IMMS, PIER, Empower, JChem, LNB and e Archive Support SQAC (Supplier Quality Audit & Compliance) for auditing of outsource partner and their CROs relating to analytical testing Involvement with other analytical / quality projects within the GQC-SM team. Closing Date for Applications: 19th December 2022 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSK Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: M.Sc. or B.Sc. and related experience 5+ years of leading and executing analytical project level activities within R&D or GSC QC/QA units Expert understanding and experience of the analytical technologies required for reference materials Experience of working in different analytical organisations within the business (e.g., primary & secondary). Knowledge on analytical method development Knowledge of analytical method validation Able to influence senior stakeholders to implement Analytical changes across the reference material outsource model Good problem-solving skills, including the diagnosis of complex Analytical technical issues and development of practical solutions Extensive knowledge of regulatory compliance requirements (e.g., FDA 21st Century GMPs) as they relate to analytical methods, laboratory controls and pharmaceutical quality Working knowledge of the application of reference materials and associated quality processes Proven ability to innovate and champion transformational change Good oral and written communication skills Is a team player and is able to work across all levels and functions Proven ability to manage tasks and meet timelines Why GSK? 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more: Annual Report 2021 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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. 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