Supplier Quality Management Lead (Analytical Department)

Site Name: UK - County Durham - Barnard Castle Posted Date: Feb 2 2023 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. Supplier Quality Management Lead ( Analytical Department) (Secondment until December 2024) As a Supplier Quality Management Lead, you will be responsible for managing and maintaining the systems used to release starting materials for our finished products. You will provide expert advice on supplier changes, vendor complaints and Corrective and Preventative Actions (CAPA), this includes the creation and review of Raw Material Specifications alongside the monitoring of the Supplier Quality Workflow. Applicants must have manager approval to be released before applying. In This Role: Oversight of new Active Pharmaceutical Ingredients (API)/Raw Materials, raising Change Controls in SAP and allocating tasks to ensure the Supplier is suitable and the material specifications are created. Creating and reviewing agreements between Suppliers and site for specifications and purchase requirements. Active management of Vendor Complaints working closely with the suppliers to ensure appropriate actions are progressed. Raising, checking and approving Change Controls for progression of new and existing excipients and non-GSK API testing requirements against pharma/regulatory standards. Checks on the Supplier of a Packaging or Raw Material to ensure they meet the expected quality standards. Creating and approving the relevant Certificate of Analysis (C of A) acceptance reports to allow material deliveries to be accepted. Reports must be reviewed and updated as required. Review and update Distribution Risk Assessment (DRA) as required by assessing API transportation to site from the Supplier ensuring compliance. Reviewing the quality systems in place for Suppliers not within scope of the audit process by performing desktop audits and generating the subsequent reports. Closing Date for Applications: 8th February 2023 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? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Degree in Science or Engineering related discipline preferred. The ability to approach and discuss scientific data. Strong communications skills, able to communicate at all levels internally and externally. Experience using various electronic systems e.g. SAP, VQD Good attention to detail, able to multitask and prioritise workload. Must have good interpersonal skills Preferred Qualifications/ Experience If you have the following characteristics, it would be a plus: Laboratory background would be advantageous Broad understanding of the structure and operation of the site RMQC specification set up Appreciation of GMP requirements as defined in CFR 21 Part 11 Detailed knowledge of the quality systems and processes that operate within the laboratory and Operational quality areas on site Specific Detail Linked to the Role: Secondment opportunity until December 2024 Desk based role with the opportunity for flexible working Monday to Friday dayshift hours apply (based on a 37.5 hour working week) 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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