Job description Site Name: UK - Angus - Montrose Posted Date: May 12 2025 There is a new opportunity for a Validation Lead to join the team at Montrose in our Quality team. The Quality team exists to deliver compliant, effective and efficient services in the area of Quality to the GSK Montrose site. The purpose of the Validation Lead is to ensure that validation activities for the GSK Montrose site are performed in an efficient and compliant manner, this includes • Validation challenges are resolved in an effective and timely manner • Interfaces with project teams are effective for both parties • Significant validation or compliance issues are escalated and resolved through the appropriate management lines and/or management processes. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will The job holder will lead site validation activities acting as the Subject Matter Expert (SME) for site validation activities Ensure site or project activities associated with validation (e.g. plant and equipment qualification, process validation, cleaning validation, computer and control system validation, analytical equipment qualification) are in compliance with GSK quality management system requirements, including with relevant GMP requirements e.g. EU GMP, US GMP, Japanese GMP. Deputise for the Operational Quality Leader, as directed. Ensure that the site is aware of the latest guidelines/company standards on validation. Assess and approve Change Control to confirm no adverse effect on GMP or validation status Drive and improve validation standards ensuring validation activities are carried out in accordance with relevant GSK Policies and Procedures. Participate in continuous improvement processes for simplifying validation and manufacturing related processes while also driving improvements in quality and validation effectiveness. Participate in audits and inspections as validation Subject Matter Expert. Manage daily operational activities with a positive and proactive ‘zero overdue’ culture. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Scientific qualification e.g. HNC, HND, BSc, BEng or significant experience in the application of quality/compliance principals within a pharmaceutical environment In-depth knowledge of GMP with ideally experience working in a GMP manufacturing environment. Experience in validation, quality and compliance, as applied to pharmaceutical API. Experience with plant and equipment qualification, process validation, cleaning validation, computer and control system validation, analytical equipment qualification. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Knowledge of how APIs are manufactured. Knowledge of regulatory inspections and internal audits. Audit experience Closing Date for Applications – 25th May 2025 (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. 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 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 on Ukdiversity.recruitment@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. 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