Site Name: UK - Hertfordshire - Ware Posted Date: Jan 14 2025 The Quality function promotes quality and compliance through the product life-cycle in the manufacturing and production operations across GSK Sites. The team supervises all quality related systems, improvement procedures and documentation (including data and information) to ensure products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for the UK/EU markets). We are currently looking to recruit an NPI (New Product Introduction) Quality Lead at the Ware manufacturing site. The purpose of the role is to manage the quality aspects of the early-stage product lifecycle at Ware site by providing a single point of contact for site Quality activities associated with New Product Introduction and for ensuring that risks for new products are understood and mitigation plans exist. Through you will drive ownership of the PAI readiness process on site. Key Responsibilities (include): Provide a single point of contact for site Quality activity associated with new product introduction at the Ware site, working with multidisciplinary teams and across quality functions including operational quality, regulatory, validation and analysis teams. Providing expertise within Quality for NPI activities at the Ware site. Interact directly with the central Strategic Product Quality Team to ensure that harmonized approaches and/or best-practice are established at the Ware site. Identify the wider implications of Quality-related issues, ensuring that, where necessary, Quality risks are escalated, and that resolution of issues is compatible with business aims and Quality expectations Manage and coordinate the site review of NPI regulatory submissions and responses to questions, to ensure that Quality and Compliance aspects are addressed appropriately Ensure PAI activity is planned and executed, and host Pre-PAI assessments and PAI inspections to support regulatory file approvals. Ensure relevant Quality expertise and associated Quality standards are available to support new technologies/novel equipment introduction at Ware site. About You: You will be solution oriented, with a proven ability to resolve issues and work autonomously whilst also being a high performing member of a team. Good working knowledge and understanding of the complexities and importance of supply chain and production within a highly-regulated manufacturing environment (to ensure safety, quality and supply are the focus) are key to the role. You will also bring strong communication skills and an ability to build effective working relationships across all departments and levels of seniority. You will be resilient and calm with a high level of accountability to drive successful outcomes. About Ware Manufacturing Site: We are co-located with our R&D colleagues and recently opened a new, state-of-the-art oral solid dose facility at Ware. At this location our scientists, technicians and engineers (from R&D and Global Supply Chain - GSC) work collaboratively together (using the latest technologies) to rapidly knowledge transfer and deliver GSK's most innovative, medicines faster and more efficiently. On site we produce over 60 million respiratory inhalers each year with growing demand in future years. The site also processes Active Pharmaceutical Ingredient (API) for use both on site and other manufacturing sites in our network. APPLICATION CLOSING DATE - Wednesday 29th of January 2025 (COB). Basic Qualifications: Relevant experience and qualifications (eg; Scientific or Engineering discipline and Manufacturing/Technical experience obtained from within a highly regulated manufacturing industry is essential Operational knowledge and understanding of manufacturing processes (including cGMP) in a pharmaceutical environment. Benefits: GSK offers a range of benefits to its employees, which include, but are not limited to: Competitive base Salary Annual bonus based on company performance Opportunities to partake in on the job training courses Opportunities to attend and partake in industry conferences Opportunities for support for professional development/chartership Access to healthcare and wellbeing programmes Employee recognition programmes Hybrid (onsite/remote) working within GSK policies (post training period) If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK. 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. 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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