85 GSK jobs in England & Wales

As Conformance Specialist you will develop and provide input to regulatory strategies, change control and compliance issues for the manufacture and registration of established API (Active Pharmaceutical Ingredients), Finished Products and New Product Introductions (NPIs). The role ensures site compliance by the interpretation of corporate standards (e.g. the QMS), pharmacopoeial requirements, regulatory authority directives, license renewals/annual reports and commitments made to regulatory authorities. You will support the Quality Assurance department and all manufacturing units across the site by handling compliance to all licences in all markets supplied (directly or via a packaging site)., Act as product regulatory specialist for the site:

• Provide product regulatory advice for the impact of all changes made on site (e.g. Reg Advice 1) ensuring regulatory compliance in all markets
• Maintain product quality specifications to ensure manufacturing and release and end of life testing complies with registered details and pharmacopoeial requirements.
• Provide and approve regulatory information for periodic product reviews
Act as the primary site contact with central regulatory groups (pre and post approval) and Local Operating Companies (LOCs), making decisions on behalf of the site:
• Develop regulatory strategies using innovative thinking to support site and business strategies/priorities (NPI & existing products - line extensions), approving plans for wave 3 launches
• Review and approve all regulatory documents (submissions, variation dossiers, licence renewals, response to questions and annual reports) to meet GSK submission & launch dates and without undue regulatory restriction on company operations.
Support regulatory compliance on site:
• Internal and external audits
• Regulatory/Pharmacopoeial Intelligence
• Provide support to maintain statutory Site licenses.
• Lead or assist with quality and compliance-related deviations.
  
  As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated person who has experience of working in quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people skills and a proven ability to drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills., Relevant qualifications (eg; HND or 'A' levels in scientific, technical engineering discipline) or equivalent experience, ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly regulated industry).
• Knowledge of current Good Manufacturing Practice (cGMP) requirements.
• Experience obtained working in highly regulated industry, including knowledge and application of the principle of the Quality Management Systems (QMS).
  
  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., 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., Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov

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
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.