Operational Quality Advisor

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Position Summary The Operational Quality Advisor plays a crucial role in maintaining the quality and compliance of various materials and processes within the GSK Irvine site. You will be responsible for the release of raw materials, starting materials, intermediates, drug substance and blends. This role is critical for ensuring that the products manufactured by the organisation are safe, effective, and of high quality, ultimately protecting patient safety and maintaining the overall quality assurance. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Participate in assessment of non-conformances with cGMP, deviations and customer complaints investigations and ensure that appropriate CAPA has been identified and verification of CAPA effectiveness and deviation trending is carried out. Approve master batch sheets, SOPs, specifications and methods to ensure compliance with GMP and licence registrations. Participate in Operational Quality approval of changes in a compliant manner to ensure that proposed changes are planned and evaluated. Plan, conduct and document internal quality audits to ensure GMP compliance. Evaluate site Right First time performance and drive improvements in the RFT figures Complete product stability protocols and periodically evaluate the stability profiles to ensure the quality of the products manufactured. Provide support and advice both informally and through quality councils to Operations to ensure continued business compliance. Review of batch documentation, test results and all other documentation associated with certification (for EU) and release of Finished Product Provide Batch certification for release. Review and approve of Technical Terms of Supply (TTS) and associated quality agreements to include review and approval of changes and assessment of deviations and trends. Approve distribution risk assessments to assure compliance with cGMP. Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Degree or HNC/HND or equivalent with relevant GMP experience Strong organizational and decision-making skills, excellent communication skills, and ability to manage change. Experience within the Pharmaceutical Industry including an in-depth knowledge of cGMP/GQLP and Quality issues. Preferred Qualification If you have the following characteristics, it would be a plus: Experience of working in the GMP operational environment. Experience in systems utilized for role, such as SAP / M-ERP, VQMS. This role is based in the United Kingdom at the Irvine site. Closing Date for Applications – 13th February 2026 (COB) 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. How to apply If this role feels like your next step, please apply and briefly tell us how your experience meets the responsibilities and qualifications. If you need any reasonable adjustments during the recruitment process, please tell us. We look forward to hearing from you. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [email protected] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. 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For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are 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 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 on our career site.